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Drug News

New Drug Approval Updates 1999




Targretin (bexarotene)

December 30, 1999

ST. LOUIS, (MD Consult) - On December 30, 1999, US Ligand Pharmaceuticals announced the Food and Drug Administration (FDA) had approved for marketing Targretin (bexarotene) capsules for once-daily treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. The FDA approved the drug for both early- and advanced-stage CTCL.

Side effects associated with Targretin in clinical studies were reversible lipid abnormalities (79%), hypothyroidism (29%) and leukopenia (17%).

For full prescribing information on Targretin (bexarotene), visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Avelox (moxifloxacin HCl)

December 13, 1999

ST. LOUIS, (MD Consult) - On December 13, 1999, the U.S. Food and Drug Administration (FDA) approved the Bayer Corporation's Avelox (moxifloxacin HCl). Avelox is a new quinolone antibiotic used for the treatment of acute sinusitis, acute bacterial exacerbations of chronic bronchitis, community-acquired pneumonia, and uncomplicated skin and skin structure infections.

Avelox has been approved for marketing in eight countries, including Germany and Switzerland.

For full prescribing information on Avelox (moxifloxacin HCl), visit the Web site of Bayer. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Keppra (levetiracetam)

December 2, 1999

ST. LOUIS, (MD Consult) - UCB Pharma, Inc. announced on December 2, 1999, that the Food and Drug Administration approved KEPPRA (levetiracetam) tablets, an antiepileptic drug indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. KEPPRA's approval within ten months of NDA submission makes it the fastest antiepileptic drug approved to date.

"KEPPRA is an important new treatment for the management of epilepsy because treatment is initiated with an effective daily dose (500 mg BID) and it contributes valuable additional seizure control without concern for interactions with concomitantly administered antiepileptic drugs," said Tony Tebbutt, President of UCB Pharma, Inc.

KEPPRA is rapidly absorbed after oral administration and food does not affect the extent of bioavailability. Pharmacokinetics are linear and steady state is achieved after two days of multiple twice daily dosing.

In clinical studies, Keppra was generally well tolerated by patients. Keppra use is associated with the occurrence of central nervous system adverse events classified as somnolence and fatigue, coordination difficulties and behavioral abnormalities.

For full prescribing information on Keppra (levetiracetam), visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Aggrenox (aspirin/extended-release dipyridamole)

November 22, 1999

ST. LOUIS, (MD Consult) - On November 22, 1999, the FDA approved Boehringer Ingelheim's Aggrenox (aspirin/dipyridamole combination) 25 mg/200 mg capsules dosed twice daily for the prevention of secondary stroke and transient ischemic attacks.

Results from the European Stroke Prevention Study 2 indicate that Aggrenox reduces the risk of recurrent stroke by 37 percent compared to placebo, and by 22 percent over aspirin (50mg/day) alone.

Side effects associated with Aggrenox include headache, increased risk of bleeding and gastrointestinal symptoms.

For full prescribing information on Aggrenox, visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Tamiflu (oseltamivir phosphate)

October 28, 1999

ST. LOUIS, (MD Consult) - On October 28, 1999, Hoffmann-La Roche announced that Tamiflu (oseltamivir phosphate) was approved by the US Food and Drug Administration (FDA) for the treatment of all common strains of influenza.

Tamiflu is the first neuraminidase inhibitor in pill form and is indicated for the treatment of uncomplicated acute illness due to influenza infection in adults who have been symptomatic for no more than two days. The recommended dose is 75 mg twice daily for five days.

The medication, which belongs to a new class of drugs called neuraminidase inhibitors, targets one of the two major surface structures on the influenza virus, the neuraminidase protein. If neuraminidase is inhibited, the virus is unable to spread and infect other cells. Tamiflu is a systemic treatment for influenza, designed to reach all key sites of infection in the body, including the upper and lower respiratory tracts.

For full prescribing information on Tamiflu (oseltamivir phosphate), visit the Web site of Hoffmann-La Roche. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Aromasin (exemestane)

October 21, 1999

ST. LOUIS, (MD Consult) - On October 21,1999, the Food and Drug Administration approved Pharmacia & Upjohn's Aromasin (exemestane) tablets for treatment of advanced breast cancer in postmenopausal women.

Aromasin (exemestane) is the first aromatase inactivator approved for use in advanced breast cancer that is non-responsive to tamoxifen therapy. The most common side effects of the drug include hot flashes, nausea, fatigue, increased sweating and increased appetite.

For full prescribing information on Aromasin (exemestane), visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Comtan (entacapone)

October 20, 1999

ST. LOUIS, (MD Consult) - On Oct 20, 1999, the US Food and Drug Administration granted approval to Novartis Pharmaceuticals Corp. of East Hanover, New Jersey, to market Comtan (entacapone).

Entacapone is an adjunctive treatment for patients with idiopathic Parkinson's disease who experience the signs and symptoms of end-of-dose "wearing-off" of levodopa (so called "fluctuating" patients). Entacapone can be used in addition to levodopa therapy without any evidence of adverse effects.

For full prescribing information on Comtan (entacapone), visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Tikosyn (dofetilide)

October 5, 1999

ST. LOUIS, (MD Consult) - Pfizer Inc. announced on October 5, 1999 that the U.S. Food and Drug Administration has approved the anti-arrhythmic agent Tikosyn (dofetilide). Tikosyn is indicated for the maintenance and conversion of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter. Tikosyn is a selective potassium channel blocker and is the first new oral anti-arrhythmic for atrial fibrillation to be approved in the U.S. in the last 10 years.

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Rhinocort Aqua (budesonide) Nasal Spray

October 4, 1999

ST. LOUIS, (MD Consult) - On October 4, 1999, The US Food and Drug Administration (FDA) approved AstraZeneca's budesonide-containing Rhinocort Aqua nasal spray for the management of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older.

Rhinocort Aqua Nasal Spray is the first corticosteroid-based nasal spray approved for allergic rhinitis that allows once-daily dosing.

The recommended starting dose for adults and children 6 years of age and older is 64 mcg per day administered as one spray per nostril of RHINOCORT AQUA 32 mcg Nasal Spray once daily. The maximum recommended dose for adults (12 years of age and older) is 256 mcg per day administered as four sprays per nostril once daily of RHINOCORT AQUA 32 mcg Nasal Spray, or as two sprays per nostril once daily of RHINOCORT AQUA 64 mcg Nasal Spray, and the maximum recommended dose for pediatrics (<12 years of age) is 128 mcg per day administered as two sprays per nostril once daily of RHINOCORT AQUA 32 mcg Nasal Spray or one spray per nostril once daily of RHINOCORT AQUA Nasal Spray.

For full prescribing information on Rhinocort Aqua (budesonide) Nasal Spray, visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Evista (raloxifene)

September 29, 1999

ST. LOUIS, (MD Consult) - On September 29,1999, the FDA approved Eli Lilly's Evista (raloxifene) for the treatment of osteoporosis in postmenopausal women. This is the second U.S. indication for Evista, which was first approved for the prevention of osteoporosis in postmenopausal women. Evista is the only selective estrogen receptor modulator (SERM) on the market to both prevent and treat postmenopausal osteoporosis.

Findings from the ongoing Multiple Outcomes of Raloxifene Evaluation (MORE) trial, a multicenter study involving 7,705 women with osteoporosis, demonstrated the effects of drug therapy on spinal fracture risk and bone mineral density (BMD). Administered once daily, Evista decreased the incidence of spinal fracture by about half. Evista also significantly increased spine and hip BMD compared with placebo.

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Synercid (quinupristin/dalfopristin)

September 21, 1999

ST. LOUIS, (MD Consult) - Synercid (quinupristin/dalfopristin) I.V., was approved September 21, 1999 by the U.S. Food and Drug Administration (FDA) to treat bloodstream infections due to vancomycin-resistant Enterococcus faecium (VREF) and skin and skin-structure infections (SSSI) caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.

Synercid is the first injectable antibiotic in a distinct class of antibacterials known as streptogramins. Synercid was developed by Rhône-Poulenc Rorer Inc. (RPR), a global pharmaceutical subsidiary of Rhône-Poulenc S.A. (NYSE:RP).

For full prescribing information on Synercid (quinupristin/dalfopristin), visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Ellence (epirubicin hydrochloride)

September 16, 1999

ST. LOUIS, (MD Consult) - The US Food and Drug Administration approved Pharmacia & Upjohn's Ellence (epirubicin hydrochloride) as adjuvant therapy for node-positive, early-stage breast cancer on September 16,1999.

Adverse effects of epirubicin include nausea, vomiting, diarrhea, anorexia, stomatitis, hair loss, cardiomyopathy and a "slight risk" of treatment-related leukemia. Epirubicin may cause fetal damage in pregnant women and may induce premature menopause and chromosomal damage in sperm.

For full prescribing information on Ellence (epirubicin hydrochloride), visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Rapamune (sirolimus)

September 15, 1999

ST. LOUIS, (MD Consult) - On September 15, 1999, American Home Products' Rapamune (sirolimus) was approved for use in combination with cyclosporin for the prevention of organ rejection in patients receiving renal transplants.

Continuous monitoring of renal function is suggested when Rapamune is in use. Medical intervention might be needed because Rapamune can increase the risks of infection, lymphoma, blood pressure, plasma cholesterol and triglycride levels.

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Repronex (menotropins for injection)

August 27, 1999

ST. LOUIS, (MD Consult) - On August 27,1999, Repronex (menotropins for injection, USP) was approved by the U.S. Food and Drug Administration for use in conjunction with hCG for multiple follicular development and ovulation induction in patients who have previously received pituitary suppression.

Repronex contains equal amounts of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). It is the first approved human menopausal gonadotropin (HGM) that can be self-administered subcutaneously. With subcutaneous administration, Repronex can be self-administered where IM injections generally require a partner to administer. Subcutaneous injections are not only easier to administer, but are also more convenient for the patient to schedule.

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Aciphex (rabeprazole sodium)

August 19, 1999

ST. LOUIS, (MD Consult) - A new proton pump inhibitor Aciphex (rabeprazole sodium) was approved for marketing in the US by the FDA on August 19,1999. Aciphex was approved for the treatment of erosive or ulcerative gastroesophageal reflux disease (GERD), duodenal ulcer, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Aciphex is a once-daily drug that provides 24-hour relief. The most common side effect of the drug is headache.

Aciphex is currently sold in the UK, the European Union and Japan by the trade name Parlet.

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Raplon (rapacuronium bromide)

August 18, 1999

ST. LOUIS, (MD Consult) - On August 18,1999, Organon Inc. received approval of Raplon (rapacuronium bromide) from the US Food and Drug Administration (FDA). Raplon was approved for injection as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery.

Raplon is the first and only nondepolarizing neuromuscular blocking agent that combines rapid onset and short duration of effect for tracheal intubations and other procedures.

For full prescribing information on Raplon (rapacuronium bromide), visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Cleocin Vaginal Ovules (clindamycin phosphate)

August 16, 1999

ST. LOUIS, (MD Consult) - On August 16,1999, Pharmacia & Upjohn's Cleocin Vaginal Ovules (clindamycin phosphate) was approved by the US Food and Drug Administration (FDA) for use in non-pregnant women as a 3-day treatment of bacterial vaginosis.

Cleocin Vaginal Cream has been a prescription drug in the US used as a treatment for bacterial vaginosis since 1992. Cleocin Vaginal Ovules offers the similar efficacy of the 3-day treatment duration, as well as the ease of ovule application.

For full prescribing information on Cleocin Vaginal Ovules, visit the Web site of the FDA. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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Sonata (zaleplon)

August 13, 1999

ST. LOUIS, (MD Consult) - On August 13, 1999, the Wyeth-Ayerst Laboratories unit of American Home Products received approval of Sonata (zaleplon) from the US Food and Drug administration (FDA). Sonata is approved for short-term treatment (7-10 days) of insomnia in adults.

Sonata allows for flexible administration. It can be taken whenever a patient is having difficulty falling asleep, as long as there are 4 hours or more remaining before the patient becomes active again.

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Vestra (reboxetine mesyiate)

July 30, 1999

ST. LOUIS, (MD Consult) - On July 30, 1999, Pharmacia & Upjohn announced that the company's antidepressant reboxetine mesyiate tablets (Vestra) received approval from the U.S.Food and Drug Administration (FDA). VESTRA is currently marketed by Pharmacia & Upjohn as Edronax and as Norebox in foreign countries.

Pharmacia & Upjohn will market Vestra to primary care physicians. Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, will co-market VESTRA to psychiatrists.

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Plan B (levonorgestrel)

July 14, 1999

ST. LOUIS, (MD Consult) - The US Food and Drug Administration (FDA) has approved the first progestin-only emergency contraceptive pill called Plan B for prevention of unintended pregnancy after contraceptive accident or unprotected sex.

Plan B consists of two 0.75-mg tablets of levonorgestrel. Women should take the pill once within 72 hours after sex and again within 12 hours after the first pill. Plan B is reported to reduce the risk of pregnancy to 1%, and to significantly reduce the side effects such as nausea and vomiting.

Women's Capital Corp. will distribute Plan B in the U.S. and Canada. Plan B will be available through prescription.

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Hectorol (doxercalciferol)

June 11, 1999

ST. LOUIS, (MD Consult) - Hectorol (2.5mcg doxercalciferol capsules), was approved on June 11,1999 by the U.S. Food and Drug Administration (FDA) for the treatment of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.

Hectorol is a vitamin D prohormone. Orally administered, Hectorol is inactive until transformation into active D-hormones by the liver. It has no effect on the small intestine during absorption. Hectorol treatment is expected to reduce the occurrence of hypercalcemia and hyperphosphatemia associated with oral calcitriol therapy.

For full prescribing information on Hectorol (doxercalciferol), visit the Web site of Bone Care, Inc. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.

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