Generics Industry News Search
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January 2005 News Archive |
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WOODCLIFF LAKE, N.J., Jan. 7 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Organon, Inc.'s Remeron(R) Soltab(TM) Orally Disintegrating Tablets, 45 mg (Mirtazapine Orally Disintegrating Tablets). ...
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MIAMI - January 10, 2005 - IVAX Corporation (AMEX: IVX, LSE: IVX.L) has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for finasteride tablets in 5mg dosage strength....
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Jerusalem, Israel, January 14, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval of the Company's ANDA for Fluconazole Injection, 2 mg/mL in 200 mg and 400 mg bags. A launch date has not yet been finalized.
Fluconazole is the generic equivalent of Pfizer's antifungal agent Diflucan®.
Total annual sales of this configuration of Fluconazole Injection, including brand and generic sales, are approximately $167 million....
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PITTSBURGH, Jan 18, 2005 /PRNewswire-FirstCall via COMTEX/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Applications (ANDAs) for Oxybutynin Chloride Extended-release Tablets, 5 mg and 10 mg....
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LUXEMBOURG - A top European court dealt a blow to GlaxoSmithKline PLC Thursday by allowing generic drug makers to market versions of its top-selling anti-depressant Seroxat, known as Paxil in the United States....
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Hawthorne, New York, January 20, 2005 - Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) and its affiliates and subsidiaries (Taro) reported today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for terconazole vaginal cream, 0.4%....
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NEW YORK, January 21 -- Pfizer Inc said today that the United States Court of Appeals for the Federal Circuit ruled in the company's favor in a lawsuit by generic manufacturer Teva Pharmaceuticals challenging Pfizer's patent for its antidepressant Zoloft....
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The Food and Drug Administration (FDA) today announced the tentative approval of a co-packaged antiretroviral drug regimen manufactured by Aspen Pharmacare of South Africa for the treatment of HIV-1 infection in adults. ...
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WOODCLIFF LAKE, N.J., Jan 25, 2005 /PRNewswire-FirstCall via COMTEX/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that the U.S. Court of Appeals, Eighth Circuit, has affirmed the September 2003 decision by the U.S. District Court for the District of Minnesota in the suit between Natural Biologics, LLC and Wyeth, regarding conjugated estrogens. ...
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JERUSALEM--(BUSINESS WIRE)--Jan. 27, 2005--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Levofloxacin Tablets, 750 mg....
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Jerusalem, Israel, January 28, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the company's ANDA for Glyburide and Metformin HCl Tablets, 1.25 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg....
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Jan 28, 2005 /PRNewswire-FirstCall via COMTEX/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has granted final approval for Mylan Technologies' Abbreviated New Drug Application for Fentanyl Transdermal System in 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr strengths. Fentanyl is the generic version of Alza Corporation's Duragesic(R).
The product will be shipped immediately....
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Jan. 28, 2005 - Merck & Co., Inc. announced today that the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., vacated the August 2003 decision of the U.S. District Court in Delaware, and found Merck's patent claims for once-weekly administration of FOSAMAX® (alendronate sodium) to be invalid. ...
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