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Teva Pharmaceutical has filed an abbreviated new drug application (ANDA) to market a generic version of AstraZeneca’s schizophrenia treatment Seroquel, one of two drugs key to AstraZeneca’s future growth after several recent setbacks.
Four generic drugmakers received final approval from the FDA Sept. 14 to market generic equivalents of sanofi-aventis’ rheumatoid arthritis treatment Arava (leflunomide) in 10- and 20-mg tablets.
The FDA’s Florida District office has placed Andrx’s pending abbreviated new drug applications (ANDAs) on hold due to manufacturing problems — a move that could potentially threaten the generic firm’s portfolio of previously approved drugs.
Momenta Pharmaceuticals has formally started the ball rolling on its effort to market a generic version of sanofi-aventis’ blood thinner Lovenox, a move which could ultimately pave the way for generic biologic drugs.
Sanofi-aventis’ antithrombotic Lovenox could soon be open to generic competition as a result of a federal court ruling that invalidated the firm’s patent on the drug.
Generic drugmaker Able Laboratories has recalled its full product line and ceased it manufacturing operations after an internal review of its operations revealed apparent departures from standard operating procedures.