Glaxo's Zovirax cream for cold sores approved by FDA December 31, 2002
FDA approves Berlex rosacea drug December 26, 2002
FDA approves Abbott's once-daily epilepsy drug in US December 24, 2002
Fertility drug Bravelle approved for in vitro fertilization December 23, 2002
GlaxoSmithKline combination vaccine receives FDA approval December 17, 2002
Aventis says FDA approves Taxotere for lung cancer December 4, 2002
FDA approval of Lilly's Strattera for ADHD increases options December 2, 2002
Aripiprazole for schizophrenia approved by FDA November 20, 2002
FDA Approves Zetia as Cholesterol-lowering Treatment October 29, 2002
Bristol-Myers Combination Drug Metaglip Approved for Type II Diabetes October 23, 2002
FDA Approves Roche's Pegasys for Treating Hepatitis C October 18, 2002
New Hypertension Drug Approved by FDA October 1, 2002
Aventis Pasteur Will Launch Preservative-free Influenza Vaccine for Infants September 13, 2002
Stiefel Labs Acne Gel Approved by FDA August 29, 2002
Aranesp for Anemia in Cancer Patients Approved by FDA July 23, 2002
FDA Approves GlaxoSmithKline's Larger Wellbutrin SR Dose June 19, 2002
FDA Approves Vfend for Treatment of Invasive Aspergillosis May 29, 2002
FDA Approves Infertility Treatment May 8, 2002
AstraZeneca's Faslodex for Metastatic Breast Cancer Approved by FDA April 26, 2002
Novartis' Zometa for Bone Metastases Approved by FDA February 25, 2002
Pegylated Filgrastim Approved by FDA February 4, 2002
FDA approves Relpax for acute migraine December 30, 2002
Cyclosporine product for chronic dry eye therapy approved by FDA December 26, 2002
Novartis' Gleevec receives FDA approval as first-line CML treatment December 24, 2002
Clozapine for suicide prevention approved by FDA December 20, 2002
FDA approves Bayer's once-daily Cipro December 17, 2002
Romark's nitazoxanide for pediatric diarrhea gets FDA approval December 3, 2002
Lilly's osteoporosis drug Forteo approved by FDA November 27, 2002
FDA approves chemotherapy drug mitomycin November 18, 2002
FDA Gives GlaxoSmithKline Approval for Glitazone-Metformin Combo Drug October 23, 2002
Glaxo's Pfizer's Zyrtec Approved for Children as Young as Six Months October 23, 2002
Buprenorphine Gets FDA Approval as Schedule III Agent for Drug-abuse Therapy October 10, 2002
FDA Grants Conditional Approval for Schizophrenia Drug Aripiprazole September 4, 2002
Second-generation Antidepressant Approved by FDA August 16, 2002
Xyrem, as Controlled Substance, Approved for Narcolepsy by FDA July 19, 2002
Limited Reintroduction of Glaxo's Lotronex Approved by FDA June 10, 2002
FDA Approves Once-daily Version of Ritalin June 7, 2002
Remodulin Approved by FDA for Pulmonary Hypertension May 23, 2002
FDA Approves New Application for InKine's Visicol Formulation March 15, 2002
FDA Approves IDEC's Radioimmunotherapeutic Cancer Drug February 21, 2002
One-month Formulation of Leuprolide for Prostate Cancer Approved by FDA January 25, 2002
December 31, 2002
ST. LOUIS (MD Consult) - GlaxoSmithKline's Zovirax Cream 5% (acyclovir) for treating recurrent herpes labialis, or cold sores, in patients over age 12 has been approved by the US Food and Drug Administration (FDA).
Biovail Corp. has US marketing rights to the product. The companies said they had expanded their agreement on the drug, which also covers Zovirax ointment, an already-marketed treatment for genital herpes.
Under the new deal, Biovail said it had paid Glaxo $40 million to extend its rights to the products to 20 years from the original 10 years.
Biovail said it expected US approval for the cream in time for a second-quarter 2003 launch.
Approval of the cream was based on two randomized, vehicle-controlled, double-blind phase III studies, the FDA said. The active cream demonstrated a modest treatment benefit of about half a day compared with vehicle, the agency said.
The cream showed the potential to cause dermal irritation in the studies, but the overall safety profile appeared similar to another marketed product in the same class, penciclovir 1%, the FDA said.
December 30, 2002
ST. LOUIS (MD Consult) - Pfizer Inc. has received approval from the US Food and Drug Administration (FDA) to market acute migraine drug Relpax (eletriptan).
The drug has received US clearance for 20-mg and 40-mg tablets, the FDA said.
Pfizer received approval in the summer of 2002 to market Relpax in all member nations of the European Union in 20-mg, 40-mg and 80-mg tablets. Relpax is also sold in Japan.
Seventy-seven percent of subjects in clinical trials treated with an 80-mg dose of Relpax and 65% of subjects treated with a 40-mg dose experienced headache relief within two hours, according to Pfizer.
Pfizer hasn't indicated whether they would continue to pursue US approval for an 80-mg tablet, data for which were included in the marketing application. The approved US labeling for Relpax says an 80-mg dose was associated with increased incidence of adverse events and the maximum recommended single dose of the drug is 40-mg.
If the headache improves and then returns, a repeat dose may be taken two hours after the initial dose, the labeling says.
Relpax is a 5-HT 1b/1d agonist. Pfizer submitted the US marketing application for the drug in late 1998 but experienced delays linked to the FDA's request for a study to provide short-term cardiovascular data.
December 26, 2002
ST. LOUIS (MD Consult) - Berlex Laboratories Inc.'s Finacea (azelaic acid) gel, 15%, for topical treatment of inflammatory papules and pustules of mild to moderate rosacea has been approved by the US Food and Drug Administration.
The product will be sold by prescription.
Another Berlex azelaic acid product -- Finevin, a 20% formulation -- was approved in the US in 2001 to treat mild to moderate inflammatory acne.
Berlex Laboratories is the US subsidiary of Germany's Schering AG.
December 26, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to Allergan Inc. to market Restasis (cyclosporine ophthalmic emulsion, 0.05%) for people with keratoconjunctivitis sicca (KCS).
The FDA approval was based on a phase III study, showing that use of Restasis resulted in clinically relevant increases in Schirmer wetting when tested against vehicle, Allergan said. Increased tear production wasn't shown in patients taking topical anti-inflammatory drugs or using punctal plugs, Allergan said.
Common side effects included ocular burning, conjunctival hyperemia, discharge, excessive tearing, eye pain, foreign body sensation, pruritus, stinging, and visual disturbances such as blurring.
A FDA advisory panel previously advised against approving Restasis in July 1999. Allergan received a FDA approvable letter a month later, requesting among other things additional data.
December 24, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted approval to Abbott Laboratories Inc. to market a once-daily version of its epilepsy drug Depakote (divalproex sodium).
The approval allows Depakote ER to be prescribed in 250-mg or 500-mg tablets as either a sole or adjunctive therapy to treat complex partial seizures, plus simple and complex absence seizures, in epileptic adults, according to Abbott.
The approval was based on two clinical studies of healthy and epileptic adults, which showed the once-daily version of Depakote was as effective as regular Depakote administered twice a day or three times a day.
Depakote was first approved in 1983 as a treatment for epileptic seizures. The drug was approved for bipolar disorder in 1995 and for migraine prevention in 1996. Depakote ER was cleared for migraine prevention in 2000.
December 24, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration has approved Novartis AG's drug Gleevec (imatinib mesylate) as a first-line treatment for adult patients with newly diagnosed, Philadelphia-chromosome-positive chronic myeloid leukemia (CML).
Gleevec received marketing clearance in May 2001 under the FDA's accelerated approval program for use as second-line therapy for chronic phase patients who had failed interferon-alpha treatment. That approval was based on relatively early clinical data.
With the new approval, the third indication in about 19 months, the drug may be marketed for all three stages of CML -- myeloid blast crisis, accelerated phase and chronic phase -- before or after other treatment.
The latest approval was based on 12-month data from a large, head-to-head study that compared the drug with a combination of interferon-alpha and cytosine arabinoside, Novartis said.
About 40,000 people in the United States have CML, the FDA said.
December 23, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted approval to Ferring Pharmaceuticals Inc. to market its infertility treatment Bravelle (urofollitropin for injection) for use in in vitro fertilization.
In May 2002, Bravelle -- a human-derived follicle-stimulating hormone (FSH) -- received FDA approval for ovulation induction following pituitary suppression.
The new approval was based on clinical data showing Bravelle to be as safe and effective as Akzo Nobel NV's approved recombinant FSH Follistim in in vitro fertilization, with less injection-site pain, Ferring said.
Ferring also said Bravelle is easier to manufacture than recombinant products, and therefore less expensive.
December 20, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to Novartis Pharmaceuticals Corporation, the US subsidiary of Swiss drugmaker Novartis AG, to market its schizophrenia therapy Clozaril (clozapine) for treating recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.
This is the first time any medication has been approved to treat suicidal behavior, according to Novartis. Although generic versions of Clozaril are available, FDA regulations would provide it with exclusive rights to the new indication for 36 months.
The supplemental application was filed in March 2002, based on data from the International Suicide Prevention Trial (InterSePT), the first study to prospectively evaluate a drug for ability to reduce the risk of suicidal behavior.
An FDA advisory panel reviewed the data in November and decided Clozaril might have a favorable risk-benefit profile as a treatment for schizophrenic patients exhibiting suicidal behavior, despite the drug's serious side effects.
Clozaril, initially approved in September 1989, was the first atypical antipsychotic approved for sale in the US. But because of its link to agranulocytosis, it is only indicated for severely ill schizophrenic patients who don't respond to other medicine.
The FDA panel's decision was based on data showing that suicide is the leading cause of premature death among patients with schizophrenia and schizoaffective disorder, and these patients have an approximate 40 percent lifetime risk for suicide attempts and a 9 percent to 13 percent chance of succeeding.
December 17, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Bayer Corporation's once-a-day antibiotic Cipro (ciprofloxacin).
Bayer plans to begin shipping the new Cipro to pharmacies on January 2.
Bayer said the extended-release formulation has been approved for treating uncomplicated urinary tract infections due to susceptible strains of indicated bacteria.
The 500-mg tablet, to be sold as the brandname Cipro XR, is intended for once daily use for 3 days.
The extended-release tablets were developed using a bilayer matrix of ciprofloxacin to provide drug distribution to the serum and tissues within hours and allow sustained levels for 24 hours, according to Bayer.
The FDA approval was based on a clinical trial involving 891 adult women that showed that Cipro XR is comparable to twice-daily 250-mg doses of Cipro, Bayer said.
Bayer filed its marketing application for the extended-release tablets in March 2002. In October 2002, the company submitted a separate application to market the extended-release drug at a different dose for treating complicated UTIs. That application is still pending.
December 17, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to UK drugmaker GlaxoSmithKline to market its five-in-one combination vaccine Pediarix, which could result in 24 million fewer injections per year for US infants.
The FDA approved Pediarix for vaccination against diphtheria, tetanus, pertussis, hepatitis B and polio in infants 2, 4 and 6 months of age, resulting in up to six fewer injections under the current recommended schedule, GlaxoSmithKline said.
At present, the company said children receive approximately 20 injections in the first 2 years of life, including nine injections to protect against diphtheria, tetanus, pertussis, hepatitis B, and polio alone. Pediarix was developed to protect against these diseases with only three injections in the primary series, making it easier for parents and healthcare professionals to comply with the recommended vaccination schedule, the company said.
Pediarix was proven safe and effective in numerous worldwide clinical trials, involving 7,028 infants who received a total of 20,739 doses, GlaxoSmithKline said.
The use of Pediarix was associated with higher rates of fever relative to separately administered vaccines, the company said. But the most common side effects were similar to other vaccines and included injection-site reactions, fever, and fussiness, GlaxoSmithKline said.
The company plans to launch the vaccine in early January at a price comparable to the total cost of the individual vaccines.
GlaxoSmithKline estimates about 3 million infants in the US would qualify for the vaccination and predicted that further development of such combination vaccines may also facilitate adding new vaccines to the immunization schedule.
December 4, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration has approved anti-cancer drug Taxotere for first-line treatment of patients with non-small cell lung cancer, according to the drug's manufacturer, Aventis SA.
Aventis said in a statement that approval was based on clinical trials showing that Taxotere combined with a platinum agent indicated improved benefits to non-small cell lung cancer patients, compared with other drugs.
Non-small cell lung cancer accounts for 80% of all lung cancer cases worldwide.
December 3, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved diarrhea drug Alinia (nitazoxanide), made by Romark Laboratories of Tampa, Florida.
The oral-suspension product has been cleared for treating children between the ages of 12 months and 11 years who have diarrhea caused by Cryptosporidium parvum and Giardia lamblia. It is the first treatment to be specifically cleared by the FDA for Cryptosporidium and the first new drug for treating Giardia to be approved in the US in just over 40 years, the firm said.
Alinia, a three-day treatment, is scheduled to be launched in February, 2003.
In clinical trials, Alinia significantly reduced the duration of diarrhea caused by Cryptosporidium and Giardia infections, Romark said. Side effects were similar to those for placebo and included abdominal pain, diarrhea, vomiting and headache, the company said.
Alinia hasn't been studied in children under 12 months old or individuals over age 11, nor have its safety and efficacy been established in patients with immunodeficiencies such as HIV, the firm said.
However, Romark said it has applications pending with the FDA for nitazoxanide in tablet form for adults and for the drug as a treatment of Cryptosporidium-induced diarrhea in AIDS patients.
December 2, 2002
ST. LOUIS (MD Consult) - Eli Lilly and Company's Strattera (atomoxetine HCl), a new nonstimulant therapy for attention deficit hyperactivity disorder (ADHD), has been approved by the US Food and Drug Administration (FDA).
Strattera, the first new type of drug to be approved for ADHD in almost three decades, promises fewer side effects and no addiction risk.
Strattera will be available in January, joining the ranks of drugs such as Ritalin. It will also offer the first FDA-approved therapy not listed as a schedule II, or controlled, substance and the first ADHD drug indicated for treating adults.
The drug is a selective norepinephrine reuptake inhibitor. Although it's unknown how Strattera works, researchers believe norepinephrine plays a significant role in regulating attention, impulsivity and activity levels.
Eli Lilly said the FDA approval was based on six placebo-controlled clinical studies and a safety profile that included clinical experience with approximately 4,000 children, adolescents and adults. These studies showed the drug doesn't cause insomnia and is generally well tolerated, Lilly said.
Much of the data is still awaiting publication.
Strattera comes in a capsule and can be taken once or twice daily.
Strattera will probably be priced in the same range as other recently branded ADHD drugs, Lilly said.
Citing figures from the American Psychiatric Association, the FDA estimated that about 3% to 7% of children and another 4% of adults suffer from ADHD.
November 27, 2002
ST. LOUIS (MD Consult) - The U.S. Food and Drug Administration has approved Eli Lilly and Co.'s Forteo (teriparatide), a drug that stimulates new bone formation in patients with osteoporosis.
The FDA approved Forteo for treating osteoporosis in men and post-menopausal women at high risk for a fracture, the FDA said.
Forteo is the first approved treatment for osteoporosis that stimulates new bone formation, an FDA statement said. Other drugs work by stopping or slowing bone loss.
In animal studies to test Forteo, an increased number of rats developed osteosarcoma, according to the FDA.
No osteosarcomas were reported in human studies, the FDA statement said, but the possibility that humans treated with Forteo may face increased risk of developing this cancer can't be ruled out. This safety issue is addressed in a black box warning on the drug's label for health professionals and explained in a Medication Guide brochure for patients.
November 20, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved aripiprazole for treating schizophrenia, according to Bristol-Myers Squibb Co. and Japan's Otsuka Pharmaceutical Company Ltd.
Aripiprazole will be available under the name Abilify, the firms said.
The marketing application was based on clinical data involving approximately 3,000 schizophrenic patients worldwide that indicated aripiprazole is much more effective than placebo, the companies said.
The incidence of therapy discontinuation due to side effects in aripiprazole-treated subjects was similar to the rate for placebo-treated patients.
Aripiprazole, discovered and primarily developed by Otsuka, is believed to work by regulating dopamine and serotonin levels.
November 18, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to SuperGen Inc. to market its proprietary formulation of the generic chemotherapy drug mitomycin, the oncology products manufacturer said.
SuperGen said it received FDA approval to market Mitozytrex, a form of mitomycin enhanced with the company's Extra drug development technology, which provides a shield to prevent leakage at the injection site.
Mitomycin is used with other chemotherapeutic agents to treat stomach, pancreas and other types of cancer. Such drugs often leak at the injection site, causing ulceration of the surrounding tissue, SuperGen said.
The launch of Mitozytrex is expected in the first half of 2003.
October 29, 2002
ST. LOUIS (MD Consult) - New Jersey-based firms Schering-Plough Corp. and Merck and Co. Inc. said the US Food and Drug Administration had approved Zetia as a stand-alone cholesterol-lowering treatment, and for use with currently available statins.
Zetia works by preventing the intestines from absorbing cholesterol, where statins inhibit the liver's natural production of cholesterol, a representative for the companies said.
Clinical trials have shown that Zetia, when given to people already taking a statin, can reduce levels of LDL cholesterol as much as 25% more than the statin alone.
Schering-Plough and Merck said they were on schedule to seek US approval for a pill containing both Zetia and Zocor, a statin made by Merck, by late 2003.
October 23, 2002
ST. LOUIS (MD Consult) - Bristol-Myers Squibb Co.'s Metaglip (glipizide and metformin HCl Tablets) has been approved by the US Food and Drug Administration (FDA) as an initial type II diabetes therapy for patients whose hyperglycemia can't be managed by diet and exercise alone.
The FDA also approved Metaglip as a second-line therapy for type 2 diabetics taking either the company's Glucophage (metformin) or a sulfonylurea, combined with a regimen of diet and exercise, but whose blood sugar levels are inadequately controlled, according to Bristol-Myers Squibb.
Metaglip combines Glucophage XR (metformin HCl) and glipizide into one pill. Bristol-Myers Squibb, which started work on Metaglip in 1998, said the two diabetes drugs work in a complementary fashion to improve blood sugar levels in patients who have had trouble managing blood sugar through previous therapy, diet and exercise.
In June, Bristol-Myers Squibb reported results of two studies involving 868 type 2 diabetes patients who were unable to adequately control blood sugars with diet and exercise.
In one study, the 329 patients in the Metaglip treatment arm had significant reductions after 24 weeks in their HbA1C measure compared to the 171 patients who received single agent metformin, and the 168 patients who received glipizide.
Bristol-Myers Squibb also said more patients in the glipizide/metformin arm were able to achieve an HbA1C level of less than 7%, the standard treatment goal recommended by the American Diabetes Association.
Metaglip tablets will be introduced to the market in three dosage strengths: 2.5 milligram/250 milligram, 2.5 mg/500 mg, and 5 mg/500 mg, the company said.
October 23, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration has given approval to GlaxoSmithKline Plc for Avandamet, a single tablet combination of Avandia (rosiglitazone) with metformin, for type 2 diabetes.
Glaxo said it plans to launch Avandamet in the United States sometime in December, 2002.
As expected, the company said Avandamet hasn't been recommended for patients with liver disease.
October 23, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration has given Pfizer's antihistamine Zyrtec a supplemental approval for use in children as young as six months, the FDA said.
Zyrtec (cetirizine hydrochloride) is currently indicated to relieve symptoms of allergic rhinitis and treat itching and hives in adults and in children age two and older. It has now been cleared for those two indications in children six months and older, Pfizer said.
October 18, 2002
ST. LOUIS (MD Consult) - Swiss drugs group Roche's Pegasys, a once-weekly injection, has received US Food and Drug Administration approval as a stand-alone therapy for adults with chronic hepatitis C.
The approval of Pegasys (peginterferon alfa-2a) as a stand-alone therapy had been widely expected. The focus has now changed to earning approval for the more important Pegasys combination therapy.
US marketing approval of Pegasys combined with ribavirin is expected before the end of the year, Roche said.
The therapy's recommended course is 48 weeks. Roche said Pegasys should be available at pharmacies by the start of Nov. 2002.
October 10, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved two forms of a new drug-abuse therapy, which under a recent Congressional law will become the first narcotics in the US that can be prescribed in a doctor's office.
The FDA said it approved Reckitt Benckiser Pharmaceuticals' Subutex (buprenorphine hydrochloride) and Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) tablets for preventing withdrawal symptoms from heroin and other opiates.
Both drugs will be supplied in 2 mg and 8 mg tablets that must dissolve under the tongue. The first form, Subutex, is for use at the beginning of treatment. Its companion, Suboxone, intended for maintenance treatment, contains the opiate antagonist naloxone to protect against intravenous abuse.
Buprenorphine is a narcotic believed to have less risk of causing psychological and or physical dependence than other narcotic therapies such as morphine, oxycodone or methadone, health authorities said.
Based on the abuse potential as a narcotic, the US Drug Enforcement Administration (DEA) typically would have placed the drugs in the Schedule II drug class under the Controlled Substances Act. But in July, Congress approved legislation intended to make it easier for physicians to dispense buprenorphine, and therefore make it easier for addicts to get treatment in areas without methadone programs.
The FDA and the Department of Health and Human Services recommend the DEA place buprenorphine in Schedule III under the Controlled Substances Act, a less restrictive class, the agency said.
The FDA approval was based on clinical studies involving about 2,000 patients, showing that both forms were safe and effective, the agency said. Common side effects included cold or flu-like symptoms, headaches, sweating, nausea, mood swings and difficulty sleeping.
The FDA also acknowledged reports from France, where buprenorphine has been available for years, linking the narcotic substances to a number of deaths from respiratory complications, especially when combined with alcohol or antidepressants that affect the central nervous system.
As a result, Reckitt Benckiser Pharmaceuticals and the FDA have developed a thorough risk management program designed to discourage abuse and diversion, the FDA said. The risk management program will include provisions for active and passive surveillance to identify when these drugs are being abused, the agency said.
The surveillance will include interviews with substance abusers, monitoring local drug markets, data collection, and monitoring adverse event reports, the FDA said.
The FDA said provisions of the Congressional law would also permit the agency to limit the number of patients treated by individual physicians and require physicians to get registration from the DEA, providing additional safeguards as this drug enters the office setting.
October 1, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to Pharmacia Corp. to market its hypertension drug eplerenone (Inspra), which is expected to work in a variety of patients.
Eplerenone is the first drug designed to selectively block the hormone aldosterone, a key component within the renin angiotensin aldosterone system (RAAS), which has been shown in pre-clinical and clinical studies to play a role in regulating the cardiovascular system.
Pharmacia said eplerenone lowered blood pressure alone and combined with other agents during clinical trials involving approximately 3000 participants. The most commonly reported adverse side effects included dizziness, fatigue, flu-like symptoms, diarrhea and cough. These symptoms were comparable to those seen with placebo, the firm said.
The effect of eplerenone on the morbidity and mortality of MI patients who have early complications of heart failure is also being studied, Pharmacia said.
September 13, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to Aventis Pasteur Inc., a US subsidiary of French drugmaker Aventis SA, to market a preservative-free formulation of its influenza vaccine Fluzone for infants ages 6 to 35 months.
This would be the first preservative-free influenza vaccine approved for infant administration, the Swiftwater, Pennsylvania-based company said. Due to the current manufacturing schedule, Aventis Pasteur said only a limited quantity of pediatric vaccine will be available for the 2002-2003 season.
Aventis, which supplies about 50% of the nation's flu vaccine, said it developed the pediatric form to boost public confidence in immunizing infants. Fears about using vaccines containing preservatives in infants have grown in the US since the FDA said in 1999 the amount of mercury intake for some babies in their first six months might exceed limits set by the US Environmental Protection Agency (EPA). Mercury is the main ingredient in the vaccine preservative thimerosal.
The firm can produce greater quantities of the vaccine for the 2003-2004 season and will make more if the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) strengthens its current recommendations for the annual immunization of healthy children, Aventis said.
The ACIP is considering a plan to strengthen its present recommendations to include annual immunizations of healthy children aged 6 to 23 months.
For the 2002-2003 influenza season, the infant vaccine will be packaged in pre-filled syringes and launched in early to mid-November, Aventis said.
September 4, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given an approvable letter to Bristol-Myers Squibb Company and Japan's Otsuka Pharmaceutical Company Ltd. for their investigational schizophrenia therapy aripiprazole.
Final approval of aripiprazole depends on the successful completion of ongoing discussions with the FDA, the companies said.
Aripiprazole, whose proposed trade name is Abilify, was discovered by Otsuka Pharmaceutical. The product is said to be the first of a new generation of atypical antipsychotics that may offer an improved side-effect profile.
An estimated 2 million Americans suffer from schizophrenia, Bristol-Myers Squibb said. Clinical trials of aripiprazole are ongoing for the treatment of acute mania, bipolar disease and Alzheimer's disease.
August 29, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration has given approval to Stiefel Laboratories Inc., a maker of dermatology products, to market its DUAC Topical Gel (clindamycin 1%, benzoyl peroxide 5%) for treating inflammatory acne vulgaris.
The Coral Gables, Florida-based Stiefel Laboratories also markets Panoxyl (benzoyl peroxide) soap bars and topical gels for treating acne, plus Clindets (clindamycin), topical pledgets used for treating acne vulgaris.
August 16, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to Forest Laboratories Inc. for its new antidepressant escitalopram oxalate (Lexapro), a second-generation version of citalopram (Celexa).
Lexapro, a selective serotonin reuptake inhibitor (SSRI) that is the single-active isomer of Celexa, was approved for major depressive disorder, according to Forest. The New York City-based drugmaker expects the new antidepressant to be available in pharmacies by September 5.
Lexapro's approval was based on safety and efficacy data from clinical trials of more than 1100 patients with moderate and severe depression, Forest said. In a double-blind, multicenter study, 491 patients were randomized for 8 weeks to one of four trial arms: Lexapro at 10 or 20 mg per day, Celexa at 40 mg per day, or placebo.
Lexapro showed significantly greater improvement over placebo, Forest said, but was only shown as effective as 40 mg Celexa on major efficacy outcome variables. At the primary endpoint, patients on Lexapro showed significant improvement over placebo beginning at week 2, and at the secondary endpoint, Forest said. Lexapro showed statistically significant separation from placebo at either week 1 or 2, earlier than Celexa.
Lexapro was well tolerated, Forest said, and dropout rates due to adverse events were comparable to placebo. The most common adverse events reported with Lexapro versus placebo were nausea (15% vs. 7%), insomnia (9% vs. 4%), and ejaculation disorder (9% vs. less than 1%).
July 23, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Amgen Inc.'s Aranesp drug -- a longer-lasting form of the company's older anemia drug Epogen -- to treat anemia in cancer patients receiving chemotherapy.
Amgen, based in Thousand Oaks, California, sells Epogen to treat anemia in kidney dialysis patients, but rights to the drug for other indications were licensed early to Johnson & Johnson, which sells the same drug in the US under the name Procrit for patients undergoing chemotherapy.
Studies have indicated Aranesp works when administered once every two weeks, compared with Procrit's weekly dose schedule. Both drugs must be injected.
Aranesp was started last year to treat people with chronic kidney disease. The FDA approved Aranesp to treat people with non-myeloid cancers, Amgen said.
The drug keeps its level in the blood about three times longer than previous treatments, allowing for less-frequent dosing, Amgen said.
July 19, 2002
ST. LOUIS (MD Consult) - Orphan Medical Inc.'s Xyrem (gamma hydroxybutyrate, GHB) has been approved by the US Food and Drug Administration (FDA) for some patients with narcolepsy. The FDA said distribution would be strictly controlled due to concerns about the drug, which was banned in the 1990s for its use in date rapes.
The FDA will allow Xyrem to be prescribed for patients with cataplexy associated with narcolepsy. The drug will be listed as "controlled substance," meaning it can't be sold or given to anyone other than for its intended use.
Illegal use of Xyrem will be subject to stiff penalties under Schedule I, the most restrictive list of controlled substances, the FDA said.
To prevent additional problems, the FDA has worked closely with the Minneapolis, Minnesota-based company to limit distribution of the drug and educate doctors and patients about its potential abuse as a recreational drug.
Under the program, prescribers and patients can only get Xyrem through a single, centralized pharmacy. Doctors are expected to monitor patients every three months. Orphan Medical will also provide a patient and physician registry, the FDA said.
Xyrem was approved based on the results of two controlled clinical trials that showed use of the drug reduced episodes of cataplexy in patients with narcolepsy, the FDA said. In clinical trials, 484 patients were treated with Xyrem. About 85 percent of the patients were also treated with central nervous system stimulants.
Side effects associated with Xyrem include confusion, depression, nausea, vomiting, dizziness, headache, bedwetting and sleepwalking, the FDA said. Abuse of the drug could lead to dependence, it said.
June 19, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given a supplementary approval to GlaxoSmithKline to market a 200 mg formulation of its longer-acting antidepressant Wellbutrin SR (bupropion HCL), the British drugmaker announced.
Wellbutrin SR is a sustained release version of the company's antidepressant Wellbutrin. GlaxoSmithKline also markets the new formulation as Zyban for smoking cessation.
The 200 mg tablet will offer patients currently taking 400 mg of Wellbutrin SR daily a more convenient daily dosing option, GlaxoSmithKline said. Presently, the company said, these patients have to take two 100 mg sustained release tablets twice daily to get a maximum dose.
The new 200 mg tablet should be available in US pharmacies by mid-July along with the previously approved 100 mg and 150 mg tablets, the company said.
Andrx Corp. of Fort Lauderdale, Florida, applied for FDA approval of a generic form of bupropion in 1999. Andrx is waiting for final FDA approval to market the drug.
June 10, 2002
ST. LOUIS (MD Consult) - GlaxoSmithKline's controversial irritable bowl syndrome (IBS) therapy alosetron hydrochloride (Lotronex) has received a supplemental new drug application, allowing for a limited reintroduction, from the US Food and Drug Administration (FDA).
The reintroduction will be limited to women who have severe IBS characterized predominantly by diarrhea and have failed conventional therapy. Less than 5% of IBS patients have severe disease and only a fraction of those have diarrhea-predominant disease, the FDA estimated.
Glaxo voluntarily withdrew Lotronex from the US market in November 2000, less than a year after the drug's approval, because of postmarketing reports of ischemic colitis and constipation. Some of the reports included fatalities.
Although constipation and ischemic colitis were seen in premarketing clinical trials, serious complications weren't observed until the drug was launched and more patients used it.
Under the risk-management program, physicians wanting to write scrips for Lotronex will have to enroll in a prescribing program established by Glaxo. To enroll, they must agree to educate patients about the risks and benefits of Lotronex and give them a copy of an FDA-approved medication guide. Patients will be required to sign a patient-physician agreement before receiving their initial prescription.
To ensure these conditions have been met, pharmacists will only fill prescriptions displaying a designated sticker attached by an enrolled physician. In addition, pharmacists will give patients the medication guide when the drug is dispensed. Glaxo has agreed to conduct an ongoing assessment of the program.
The reversal in Lotronex's fortunes follows a recommendation from the FDA's Gastrointestinal Drugs and Drug Safety Advisory Committees, which in April said they supported reintroducing the product for some patients.
Patients with IBS have petitioned the FDA to allow the return of Lotronex. While the condition is not regarded as life-threatening, severe IBS can make it difficult for patients to perform the activities of daily life.
FDA officials said approximately 125,000 US patients would be eligible for Lotronex under the new guidelines.
They said the drug's new label will provide guidance to physicians about identifying patients who qualify for therapy. The doctors will be responsible for making the decision, and off-label prescribing may occur.
The FDA officials said they felt the risk of some patients receiving Lotronex even if they don't qualify is outweighed by the importance of geeting the medication to patients with severe symptoms.
GlaxoSmithKline said it will be 4 to 6 months before Lotronex can be re-launched, as the risk management program hasn't been finalized and the FDA must sign off on several components. The company is aware of patients' concerns regarding access and insurance coverage and will consider those issues while working out the details.
June 7, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given approval to Novartis Pharmaceuticals Corp. to market a once-a-day form of its attention deficit/hyperactivity disorder (ADHD) drug Ritalin (methylphenidate HCl), developed by Ireland's Elan Corporation plc.
The Novartis AG subsidiary said it received approval for Ritalin LA, a new formulation using Elan's Spheroidal Oral Drug Absorption System (SODAS), which equates with twice-daily dosing by providing a second release four hours after administration. The new formulation should eliminate the need for children to take a midday dose at school, Novartis said.
Ritalin LA will be offered in whole capsules and beads that can be sprinkled on food for children who have difficulty swallowing, Novartis said. The medication will be available in 20, 30 and 40 mg beaded capsules.
The once-a-day formulation should be available before the fall 2002 school year.
May 29, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted approval to Pfizer Inc. to market oral and intravenous formulations of Vfend (voriconazole) for the primary treatment of acute invasive aspergillosis. It was also approved as salvage therapy for rare but serious fungal infections caused by Scedosporium apiospermum and Fusarium spp.
In immune-compromised individuals, these fungal infections have traditionally been associated with a high rate of illness and death if not treated aggressively.
The approval comes a little more than two months after the drug was cleared in the European Union.
May 23, 2002
ST. LOUIS (MD Consult) - United Therapeutics Corp.'s pulmonary arterial hypertension therapy Remodulin (treprostinil sodium) has been granted approval by the US Food and Drug Administration (FDA).
The approved indication covers NYHA class II-IV pulmonary arterial hypertension, the FDA said.
United Therapeutics received an approvable letter for Remodulin earlier this year after the FDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval in Aug. 2001.
Remodulin, a synthetic formulation of prostacyclin, is intended for subcutaneous infusion using a small device developed by Medtronic MiniMed Inc. of Minneapolis, Minnesota.
United Therapeutics said Remodulin's delivery system helps reduce the risk of sepsis.
Last year. Actelion Ltd.'s Tracleer (bosentan) became the first oral treatment for pulmonary arterial hypertension approved for sale in the US.
May 8, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted approval to Ferring Pharmaceuticals to market a human-derived follicle stimulating hormone (hFSH) for treating infertility, the company said.
Tarrytown, New York-based Ferring said its urofollitropin (Bravelle) induces ovulation when used with human chorionic gonadotropin following pituitary suppression. The company said approval was based in part on a trial in which Bravelle's safety and efficacy were equivalent to that of recombinant FSH.
Bravelle is easier to manufacture than the recombinant versions and is expected to be priced significantly lower, Ferring said. The product, extracted from the urine of postmenopausal women, is highly purified. It is available as a subcutaneous or intramuscular injection.
Bravelle should be available soon, Ferring said. The company is also seeking additional indications in infertility treatment for Bravelle.
April 26, 2002
ST. LOUIS (MD Consult) - AstraZeneca's Faslodex (fulvestrant) Injection, a selective estrogen receptor for second-line treatment of metastatic breast cancer, has been approved for marketing by the US Food and Drug Administration (FDA).
Faslodex, indicated for treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy, is administered in a monthly intramuscular injection.
Faslodex is the only estrogen receptor antagonist to be proven effective after tamoxifen therapy failure, AstraZeneca said.
The FDA approval comes about 13 months after AstraZeneca filed for approval. BR> The marketing application was based on phase III trials that compared Faslodex with Arimidex (anastrozole), AstraZeneca's approved aromatase inhibitor for breast cancer, in post-menopausal women who had been treated with hormone therapy.
In one of the trials, the median time to progression was 5.4 months among patients treated with Faslodex versus 3.4 months for patients with Arimidex treatment. The median duration of response was approximately nine months longer with Faslodex than with Arimidex.
In the other trial, which was not placebo-controlled and not blinded, time to progression was 167 days with Faslodex and 156 with Arimidex. The duration of response was similar for both drugs in the trial.
AstraZeneca plans to release results of a study comparing Faslodex with tamoxifen. The firm also will study the drug as a treatment for early breast cancer and breast cancer in premenopausal women.
March 15, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted a supplemental new drug application approval to InKine Pharmaceutical Company Inc. to market a new form of its colon-cleansing agent Visicol (sodium phosphate), the company reported.
The FDA approval is for smaller tablets containing significantly less microcrystalline cellulose (MMC) -- included in the drug as a binding agent -- than the original form.
The FDA initially approved Visicol in September 2000. Blue Bell, Pennsylvania-based InKine filed for approval of the new formulation in January and was granted an expedited review.
The new tablets will have the same brandname, but will be marked with the words "new formulation" and will include new clinical data on the drug label, InKine said.
The reformulated product will be available in the second quarter. InKine and marketing partner Procter and Gamble will introduce the product to gastroenterologists during the Digestive Diseases Week conference in May.
February 25, 2002
ST. LOUIS (MD Consult) - Novartis Pharmaceuticals Corp.'s Zometa (zoledronic acid), for the treatment of bone metastases caused by both liquid and solid tumors, has been approved by the US Food and Drug Administration (FDA).
Zometa is the first drug to be approved in the US for the prevention of such problems, which ultimately appear as a side effect of almost all progressively worsening cancers, and can be caused by a variety of tumors.
Before Zometa's approval, the only other option was Novartis Pharmaceuticals' Aredia, the first generation version of Zometa. Aredia was previously approved by the FDA for treating skeletal problems caused by breast tumors and bone cancer.
Zometa is an intravenous bisphosphonate designed to be a more powerful version of Aredia. It was initially approved by the FDA in August 2001 for treating tumor-related hypercalcemia, or elevated calcium levels in the bloodstream.
Hypercalcemia is another common side effect of cancer. Untreated, it can cause severe sleepiness and other clinically relevant adverse effects.
The supplementary indication for Zometa was filed in July 2001. In January, the company was endorsed by a FDA expert advisory committee, which voted unanimously in favor of backing its approval for the supplementary indication.
The FDA advisory committee's recommendation was based on clinical studies showing an approximately 14% decrease in the number of patients with skeletal problems when compared with placebo. About 5,000 patients participated in the studies.
Zometa's potential side effects, based on laboratory exams, appear to include possible kidney damage, the FDA committee noted.
The FDA said patients with prostate cancer should have failed at least one hormonal therapy prior to taking Zometa.
February 21, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Biotechnology company IDEC Pharmaceuticals Corp.'s drug Zevalin (ibritumomab tiuxetan) for delivering radiation directly to tumors.
The drug was approved to treat patients with low-grade non-Hodgkin's lymphoma who aren't responding to Rituxan (rituximab), a monoclonal antibody drug IDEC co-markets with Genentech Inc.
Zevalin is the first treatment to use radioimmunotherapy to kill tumors. Like Rituxan, the drug targets certain antigens on cancer cells. But unlike Rituxan, Zevalin has a radioactive isotope that delivers a dose of lethal radiation when when it attaches to cancer cells.
Investigators say Zevalin is a significant step forward in managing patients with adequate bone marrow reserves who have failed standard chemotherapy or a mix of chemotherapy and Rituxan. While standard chemotherapy is administered over 4 to 6 months, Zevalin can be administered in an outpatient setting over eight days with about 12 weeks of follow-up.
In one trial, 51% of patients who had stopped responding to Rituxan benefited from a single dose of Zevalin.
February 4, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved California-based Amgen's Neulasta (pegfilgrastim), a longer-acting form of febrile neutropenia drug Neupogen (filgrastim).
Amgen said Neulasta adds a polyethylene glycol molecule to filgrastim to extend the drug's half-life. Consequently, the drug needs less frequent dosing than Neupogen.
The FDA approval was based on two clinical trials in which the longer-acting formulation was shown to have two benefits, Amgen said. First, it reduces the number of injections needed from about 10 or 11 per complete cycle of chemotherapy to five. Second, it cut the number of hospitalizations for infections by almost half in one study and more than half in the other.
Results of the initial clinical trial are scheduled to be published in the February issue of the Journal of Clinical Oncology. The second trial is awaiting publication.
Amgen plans to submit a cost analysis to the government to show Neulasta can significantly reduce hospitalizations for febrile neutropenia, which can cost about $25,000 per patient.
The product is set to launch in April.
January 25, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Atrix Laboratories Inc.'s Eligard 7.5 mg prostate cancer drug.
Eligard, formerly Leuprogel One-Month Depot, is injected just under the skin, usually above the hip. Subcutaneously, it becomes a biodegradable implant, with a gradual release of leuprolide acetate, the active ingredient. The 7.5 mg dose is released over a one-month period.
In clinical trials, Eligard substantially reduced testosterone levels in men with hormone-responsive prostate cancer, the company said. The company believes Eligard will help repress tumors and make patients feel better.
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