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FDA Rejects Generic Tablets Larger Than Brand Citing Safety And Efficacy Concerns

 
• By Brenda Sandburg

FDA denies ANDAs for one product because the generic tablet size is larger than the brand; the agency plans to release a draft guidance on generic equivalency to the reference listed drug in size, taste and smell.

FDA has begun to reject ANDAs for generics tablets that are larger than their brand name counterpart, attorney Kurt Karst noted in a recent blog posting.

Karst, of Hyman, Phelps & McNamara, cited letters that FDA’s Office of Generic Drugs recently sent to companies with ANDAs pending for one product. The agency told them that their applications are not approvable because the larger tablet size of their products compared to the reference listed drug raises safety and efficacy issues. Karst did not identify the company or product in his

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