Teva Pharmaceutical Industries Limited Sues FDA Over Bid To Block Approval Of Generic Copaxone

Teva Pharmaceutical Industries Ltd. (TEVA) sued U.S. regulators seeking to block approval of a generic version of its multiple-sclerosis drug Copaxone, a product that accounts for more than half the company’s revenue and is set to go off patent on May 24. Teva, based in Petach Tikva, Israel, contends in the complaint that U.S. Food and Drug Administration officials improperly dismissed the drugmaker’s calls to subject competitors’ generic versions of Copaxone to extensive testing before they go on the U.S. market. The suit, filed in federal court in Washington, is the company’s latest move in its campaign to block generic rivals such as Mylan Inc. (MYL:US) and Novartis AG (NOVN)’s Sandoz unit from putting out a less-expensive version of Copaxone.

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