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Set Up E-mail Alerts For FDA » RSS Feed For FDA »Mylan Inc. (NYSE: MYL) announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Linezolid Tablets, 600 mg.
Linezolid Tablets, an antibiotic, are the generic version of Pharmacia and Upjohn's Zyvox(R) Tablets, which had U.S. sales of approximately $422 million for the 12 months ending March 31, 2008, according to IMS Health.[SM]
APP Pharmaceuticals, Inc. (Nasdaq: APPX) received final approvals from the FDA of its Abbreviated New Drug Applications (ANDAs) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril Injection.
Mylan Inc. (NYSE: MYL) received tentative approval from the FDA for its Abbreviated New Drug Application for Linezolid Tablets, 600 mg.
Linezolid Tablets, an antibiotic, are the generic version of Pharmacia and Upjohn's Zyvox(R) Tablets, which had U.S. sales of approximately $422 million for the 12 months ending March 31, 2008, according to IMS Health.
Adolor Corporation (Nasdaq: ADLR) issued an update on the Entereg(R) (alvimopan) Program for chronic opioid bowel dysfunction (OBD), under development in collaboration with GlaxoSmithKline (NYSE: GSK).
The U. S. Food and Drug Administration (FDA) has concluded that clinical investigations relating to alvimopan in OBD may now proceed, and has therefore lifted the clinical hold on the OBD Investigational New Drug Application.
SkyePharma PLC (Nasdaq: SKYE) announces that its third Phase III efficacy study evaluating FlutiformTM for the treatment of mild to moderate asthma in adolescent and adult patients has met its primary endpoints.
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