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After Ignoring Letters From US FDA, Teva And Cipla Will Have ANDAs Withdrawn

 
• By Brenda Sandburg

Watson (now Teva) and InvaGen (now Cipla) failed to submit new bioequivalence data following enforcement action against Cetero Research.

Building icon with inscription FDA and flag of The United States over abstract background. - Illustration

After a six year effort, the US Food and Drug Administration has run out of patience with Watson Laboratories Inc. and InvaGen Pharmaceuticals Inc. and is moving to withdraw approval of two of their abbreviated new drug applications because the firms failed to conduct additional bioequivalence studies for the products.

The companies' ANDAs were supported by bioequivalence studies conducted by Cetero Research, the contract research organization that the agency concluded had falsified documents and manipulated samples across a number of studies

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