Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the Food and Drug Administration (FDA) has provided guidance regarding the Abbreviated New Drug Application (ANDA) for M-Enoxaparin. Momenta is developing M-Enoxaparin, a technology-enabled generic version of Lovenox(r), in collaboration with Sandoz, the generics division of Novartis AG.
Earlier this year, Momenta and Sandoz submitted a proposal to FDA for addressing the potential immunogenicity of M-Enoxaparin, in response to FDA's letter of November, 2007. On April 28, 2008, FDA responded to the proposal and provided additional guidance which indicated their general concurrence with the Company's approach and proposal. FDA also requested additional data from in vitro and in vivo animal tests, the testing of additional samples for tests previously proposed, and additional information regarding certain of the methods proposed. The agency has not requested human clinical trials at this time.
"We are pleased that the FDA has clarified our path forward for M-Enoxaparin by providing written direction regarding their expectations for our application," commented Craig A. Wheeler, Chief Executive Officer of Momenta. "We are still evaluating the FDA's guidance, but, based on our preliminary assessment, we hope to submit the amendment containing the requested additional data in the third quarter."
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