Endo Pharmaceuticals (ENDP: Quote) said it has filed an amendment to its Citizen Petition with the FDA calling on FDA to publicly address numerous concerns raised by Endo and other experts about approval requirements for generic versions of LIDODERM, or lidocaine patch 5%.
The amended Citizen Petition highlights the growing scientific and regulatory support for requiring generic manufacturers to conduct comparative clinical endpoint studies to demonstrate bioequivalence to locally acting topical products like LIDODERM. The amended Citizen Petition also raises several new issues that need to be resolved before FDA approves a generic formulation of LIDODERM.
The amended Citizen Petition asks FDA to address the repeated public statements by scientific experts and FDA officials that pharmacokinetic studies, which measure the level of a drug in the bloodstream, have not yet been validated as a bioequivalence method for locally acting topical drugs like LIDODERM.
The amendment also points out that FDA has not produced any evidence indicating that pharmacokinetic studies are sufficiently sensitive to determine whether a proposed generic product will replicate LIDODERM's clinical effect.
Ivan Gergel, Executive Vice President of R&D and Chief Scientific Officer at Endo, said, "..FDA must publicly address the many unanswered questions from the original petition, as well as the additional concerns raised in this amendment, before taking any formal steps toward the approval of a generic version of LIDODERM."
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by RTT Staff Writer
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