MEBENDAZOLE GENERIC PRODUCTS MUST UNDERGO CLINICAL OUTCOMES STUDIES

15 Aug 1994
News

The Pink Sheet pinkeditor@informa.com

Executive Summary

MEBENDAZOLE GENERIC PRODUCTS MUST UNDERGO CLINICAL OUTCOMES STUDIES as a requirement for ANDA approval, FDA said in a July 1 letter to Janssen Pharmaceutica. "Because of mebendazole's poor bioavailability and nonsystemic action, FDA will require generic applicants to perform in vivo studies and in vitro dissolution testing using the test or reference product from the same batch" of the oral anthelminthic, the agency said.

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MEBENDAZOLE GENERIC PRODUCTS MUST UNDERGO CLINICAL OUTCOMES STUDIES

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