November 15, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved the proton pump inhibitor Aciphex (rabeprazole sodium) for treating Helicobacter pylori infection, Japan's Eisai Co. Ltd. announced.
The drug, originally approved in the US in 1999, is already marketed for indications including acute erosive gastroesophageal reflux disease (GERD), maintenance of healed erosive GERD, duodenal ulcers, and treating related symptoms of those conditions, Eisai said. It was developed by Eisai and is co-marketed in the US with Johnson & Johnson unit Janssen Pharmaceutica Inc.
The FDA approval clears Aciphex as a 7-day treatment for H. pylori infection, which affects up to 60 million Americans and is associated with the development of peptic ulcers, the firm said.
Current treatments require 10 to 14 days of proton pump inhibitor administration, Eisai said.
November 4, 2002
ST. LOUIS (MD Consult) - Johnson & Johnson's antimicrobial Levaquin (levofloxacin tablets/injection)has been approved by the US Food and Drug Administration (FDA) as a treatment for nosocomial pneumonia.
Levaquin is already indicated to treat community-acquired pneumonia resulting from penicillin-resistant S. pneumoniae, acute maxillary sinusitis, or acute bacterial exacerbation of chronic bronchitis.
Johnson & Johnson unit Ortho-McNeil Pharmaceuticals Inc. requested approval for the nosocomial pneumonia indication in January, 2002.
October 23, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given drugmaker Bristol-Myers Squibb Company supplementary approval permitting the use of its type 2 diabetic therapy Glucovance (glyburide and metformin HCl) along with thiazolidinediones (TZDs), such as Avandia (rosiglitazone) and Actos (pioglitazone).
The FDA initially approved Glucovance in August 2000 as an adjunct to diet and exercise.
The new indication is expected to give physicians another therapy option by allowing for the addition of a TZD when patients need more blood sugar control, Bristol-Myers said.
The new indication was based on results from a 24-week clinical study in which 42% of patients receiving both Glucovance and Avandia achieved a hemoglobin A1c level of <7%, the treatment goal recommended by the American Diabetes Association, the company said.
Approximately 8 million patients have been prescribed Glucovance over the last 2 years, Bristol-Myers said.
Glucovance is the next generation formulation of Bristol-Myers' initial type 2 diabetes therapy Glucophage (metformin), which lost patent protection in January, 2002.
October 21, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given an additional US approval to Bristol-Myers Squibb Co.'s antibiotic Tequin (gatifloxacin) as a treatment for uncomplicated skin and skin structure infections.
Tequin, first approved in the US in December 1999 as a treatment for respiratory infections, has been subsequently cleared for other indications including urinary tract infections and gonorrhea.
October 2, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given supplementary approval to Allergan Inc. to market its acne therapy Avage (tazarotene) for treating facial wrinkles and skin discoloration.
The Irvine, California-based firm said it received FDA approval to market the drug as an adjunctive therapy for patients under an existing skin care and sunlight avoidance program.
The FDA first approved tazarotene for treating psoriasis and acne in 2001. It is currently sold in the US under the name Tazorac. Tazarotene is a topical, receptor-selective retinoid designed to deliver effective retinoid action, Allergan said.
The supplementary US approval was based on clinical studies showing that Avage significantly reduced four key signs of skin damage due to overexposure to the sun, Allergan said. Avage didn't reverse the process, but it provided significant improvement in the skin's appearance, the company said.
September 27, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted approval to GlaxoSmithKline to market an extended-release version of its antibiotic Augmentin (amoxicillin/clavulanate potassium).
The new approval covers Augmentin XR Extended Release Tablets for treating adults with acute bacterial sinusitis (ABS) or community-acquired pneumonia (CAP) confirmed or suspected to be caused by beta-lactamase-producing bacteria such as Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae with reduced susceptibility to penicillin.
The drug is the first antibiotic to be approved for ABS and CAP caused by S. pneumoniae with reduced susceptibility to penicillin, Glaxo said.
Augmentin XR's two-layer formulation provides immediate release of amoxicillin and clavulanate potassium and then extended release of amoxicillin, Glaxo said.
The extended-release product's 62.5 mg of clavulanate inactivates beta-lactamase, Glaxo said. The company said the 250-mg or 500-mg regular-release Augmentin tablets can't be used to provide the same doses as Augmentin XR because they each contain 125 mg of clavulanate.
Glaxo said the US launch of the extended-release tablets is expected in mid-October. Glaxo won't seek to convert patients from Augmentin to Augmentin XR because the two formulations are approved for different indications.
September 11, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given an additional approval to GlaxoSmithKline Plc. for its genital herpes drug Valtrex (valacyclovir) as a one-day treatment for cold sores.
The British drugmaker said the approval was based on two placebo-controlled studies involving more than 1,850 participants with a history of recurrent cold sores.
Patients were told to start treatment at the first sign or symptom of the cold sore. They took either two grams of Valtrex twice a day for one day and placebo on day two, two grams of Valtrex twice on the first day then one gram of active drug twice on the second day, or placebo for two days.
Valtrex significantly reduced the duration of the cold sore outbreak and there was no difference between the two Valtrex-treated groups, according to GlaxoSmithKline.
August 30, 2002
ST. LOUIS (MD Consult) - Two weeks after receiving US Food and Drug Administration approval for its new antidepressant Lexapro (escitalopram oxalate), Forest Laboratories said the FDA has approved an additional labeling claim for maintenance treatment of major depressive disorder.
The drug, a selective serotonin reuptake inhibitor (SSRI), is the single-active isomer of Celexa (citalopram), a drug marketed by Forest. The company expects Lexapro to be available in pharmacies by September 5.
Lexapro is already approved in Britain, Sweden, Switzerland and Denmark. Celexa and Lexapro are licensed by Forest from Danish pharmaceuticals group H. Lundbeck A/S. Lundbeck developed Celexa, marketed as Cipramil in Europe, and Lexapro, known as Cipralex in Europe.
August 16, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) said Eli Lilly & Co.'s antidepressant fluoxetine (Prozac) has been approved for treating panic disorder.
Prozac is now cleared for the treatment of panic disorder with or without agoraphobia, according to CDER.
This approval will allow Lilly to promote the drug for an indication currently dominated by drugs such as GlaxoSmithKline Plc.'s paroxetine (Paxil) and Pfizer Inc.'s sertraline (Zoloft). However, generic fluoxetine products have given Prozac stiff competition since the branded drug lost US exclusivity a year ago.
CDER also said Prozac has been approved for the longer-term treatment of bulimia. Prior to this approval, Prozac was not indicated for treating bulimia for more than 16 weeks.
May 21, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted approval to Procter & Gamble to market a once-weekly form of Actonel (risedronate sodium) for preventing and treating postmenopausal osteoporosis, the company said.
Cincinnati, Ohio-based Procter & Gamble and US marketing partner Aventis Pharmaceuticals said the FDA approved a 35-mg tablet based on a one year study showing the once-weekly product was equal to daily dosing with the currently available 5-mg tablet.
The increase in lumbar spine bone mineral density (BMD) with the weekly regimen was similar to the change seen with daily dosing, the companies said. There was also a significant increase in hip BMD that was similar in both groups.
The new product is expected to launch in mid-June.
The 5-mg dose, also sold for the treatment of glucocorticoid-induced osteoporosis, was approved in the US in April 2000 and has been available in the EU since October 1999.
May 20, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted approval to Pfizer Inc. to market its antidepressant sertraline (Zoloft) for treating premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome, Pfizer said.
The FDA said it approved two supplementary new drug applications for Zoloft as a PMDD treatment: one for daily dosing and one for use only during the luteal phase of the menstrual cycle.
Zoloft was already indicated for depression, panic disorder, obsessive-compulsive disorder and posttraumatic stress disorder.
The first drug approved to treat PMDD was Eli Lilly's Sarafem (fluoxetine), which contains the same active ingredient as the company's antidepressant Prozac, the FDA said. That approval was issued in July 2000.
SkyePharma, which has developed a controlled-release version of GlaxoSmithKline's antidepressant Paxil (paroxetine), said it hopes to see that drug approved for PMDD this year and launched for that indication in 2003.
April 16, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Allergan Inc. product Botox (botulinum toxin type A) to improve the appearance of moderate to severe glabellar lines, or furrows between the eyebrows.
The approval applies to men and women 65 or younger.
Botox is already used for the indication off-label, but the FDA approval will allow Allergan to actively market the drug for treatment of furrows. Irvine, California-based Allergan said it will begin selling a version of the drug with dosing specific to the newly-approved indication under the tradename Botox Cosmetic.
The FDA approved Botox in 1989 for the treatment of crossed eyes and uncontrollable blinking. In December 2000, the drug won US approval for treating abnormal head position and neck pain associated with cervical dystonia.
Botox, administered by injection, improves the appearance of brow furrow lines by blocking the nerve impulses that lead to contraction of the major muscles in the forehead, Allergan said. Treatment is usually repeated at least every four months to preserve the effect.
FDA approval was based on a 12-month repeated-treatment trial of 537 patients and eight months of open-label follow-up of 373 of those subjects, Allergan said. Maximum response rate was achieved at day 30, with about 80% of Botox-group subjects identified by investigators as responders, compared with 3% of the placebo group.
The most frequently reported side effects in clinical trials include headaches, respiratory infections, temporary drooping of the eyelids, nausea and flu-like symptoms, Allergan said.
In the US, Botox is being considered as a potential treatment for excessive sweating, post-stroke spasticity, back spasms and headaches. Botox Cosmetic was approved in Canada about a year ago.
March 15, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given a supplementary approval to Janssen Pharmaceutica, the drugmaking unit of Johnson & Johnson, to market its antipsychotic Risperdal (risperidone) for delaying relapse in the long-term treatment of schizophrenia.
The FDA initially approved Risperdal in 1994. The Titusville, New Jersey-based drugmaker said the new indication addresses the 20%-50% of patients who are rehospitalized every year because of relapse.
The expanded approval was based on results of a multicenter clinical trial showing Risperdal reduced risk of relapse by 48%, Janssen said. Results of the trial, which included 300 patients, were published in the February issue of The New England Journal of Medicine.
In August, Janssen filed for the approval of a longer-acting version that is injected every two weeks.
March 1, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved the antiplatelet medication Plavix (clopidogrel bisulfate) for acute coronary syndrome (ACS).
Plavix, first approved in 1997 for patients with a recent heart attack, stroke, or peripheral artery disease, is marketed worldwide by Bristol-Myers Squibb and Sanofi-Synthelabo.
Plavix inhibits platelet aggregation and is typically administered in addition to aspirin. It reduces new ischemic events in patients who have had a heart attack or stroke and may prevent those events in patients with acute coronary syndrome, defined as unstable angina or mild MIs.
To get FDA approval for ACS, Bristol-Myers submitted data from the CURE trial, published in the August 2001 New England Journal of Medicine. In that study, Plavix reduced the risk of heart attack, stroke or cardiovascular death by 20% in ACS patients, when compared with placebo.
The American College of Cardiology and the American Heart Association are revising guidelines on ACS therapy, weighing risks and benefits of Plavix, heparin, low molecular weight heparin, and GP IIb-IIIa inhibitors.
The guidelines will be issued in a few months, an American Heart Association spokesman said.
March 1, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given Johnson & Johnson company Centocor Inc. approval to market Remicade (infliximab) for the improvement of physical function in patients with rheumatoid arthritis (RA), when used in combination with methotrexate.
Remicade, a monoclonal antibody, was designed to target and bind to the tumor necrosis factor alpha (TNF-a). The FDA previously approved it to inhibit progression of structural damage and reduce the signs and symptoms of RA, when used in combination with methotrexate.
Malvern, Pennsylvania-based Centocor said Remicade is now the only therapy indicated for physical function and to inhibit the progression of structural damage.
Remicade has also been approved in the US for treating Crohn's disease, an inflammatory bowel disease that causes pain, abdominal cramps, diarrhea, bleeding and weight loss.
February 5, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted a supplementary approval to Bristol-Myers Squibb to market a 600-mg, once-a-day version of Sustiva (efavirenz), the Princeton, New Jersey-based company said.
In September 1998, the FDA approved a 200-mg capsule to be combined with other anti-HIV drugs. The dosage for the 200-mg formulation is three capsules once-daily.
Bristol-Myers said the new tablet, which will be available by late February, could improve compliance by reducing the number of pills patients take daily.
There is no specific evidence to show compliance will improve with the new pill, but quality-of-life data shows patients find a once-a-day regimen less burdensome, the company said.
The once-daily formulation will be priced in the same range as the three-times-a-day formulation, the company said.
February 4, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has given Switzerland's Novartis AG approval to market its cancer therapy Gleevec (imatinib mesylate) for treating gastrointestinal stromal cancer (GIST).
Gleevec was approved by the FDA in May 2001 for treatment of chronic myeloid leukemia (CML). That approval received significant public attention, partly because the drug was the first specifically designed to address an underlying genetic malfunction through a process called molecular targeting.
Gleevec blocks the abnormal tyrosine kinase enzyme that plays a major role in CML, the FDA said. In GIST, Gleevec blocks a different abnormal enzyme found on the tumor cells. These abnormal enzymes are primarily confined to cancer cells, so there is relatively little damage to normal cells.
Gleevec was approved for the new indication under the FDA's accelerated approval and orphan drug programs.
The open-label study on which new approval was based enrolled 147 subjects with unresectable or metastatic GIST who received daily Gleevec therapy, the
FDA said. No patient experienced complete elimination of cancer, but 56 patients (38%) had reduction in tumor size by 50% or greater, the FDA said.
The duration of response to Gleevec has not yet been determined, the FDA said. Under the accelerated approval program, Novartis is required to conduct patient followup and other studies to measure Gleevec's real-world clinical benefit.
February 1, 2002
ST. LOUIS (MD Consult) - Sepracor Inc.'s asthma drug Xopenex (levalbuterol) has been approved by the US Food and Drug Administration (FDA) for an additional indication in children ages 6 to 11.
The US regulatory decision will allow Sepracor to sell Xopenex for pediatric use in a nebulizer at dosage strengths of 0.31 mg and 0.63 mg, the company said. The drug is already sold in the US in doses of 0.63 mg and 1.25 mg for asthmatics ages 12 and older.
Sepracor's supplemental application for the drug included data comparing Xopenex inhalation solution at the pediatric doses with racemic albuterol inhalation solution at 1.25 mg and 2.5 mg dosages in patients with mild-to-moderate asthma, the company said.
Researchers found the new pediatric doses safe and effective in children six and older.
The study was published in the December 2001 issue of the Journal of Allergy and Clinical Immunology.
Recommended dosing of Xopenex in the pediatric group is 0.31 mg three times daily, Sepracor said. Regular dosing of Xopenex shouldn't exceed 0.63 mg three times daily.
January 17, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted a supplementary approval to American Home Products Corp. subsidiary Wyeth-Ayerst Laboratories and Immunex Corporation to market the arthritis therapy Enbrel (etanercept) for the treatment of psoriatic arthritis.
Enbrel was intially approved in 1998 for treating rheumatoid arthritis (RA). The supplementary application for psoriatic arthritis was filed in July 2001 and granted priority review by the FDA in August.
Approximately 1 million US adults have psoriatic arthritis, a number substantially higher than previously believed, according to research from the National Psoriasis Foundation (NPF).
The supplementary FDA approval was based on 24-week-long phase III study involving 205 patients with psoriasis, the companies said. Results of the study were first released in November at a meeting of the American College of Rheumatology in San Francisco. After 24 weeks, about 59% of patients taking Enbrel had significant improvement in the symptoms of the disease, compared with 15% of those on placebo, researchers said.
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