Amphastar submits complaint over enoxaparin ANDA

Amphastar Pharmaceuticals Inc. (Rancho Cucamonga, Calif.) said it submitted a complaint to FDA requesting that CDER Director Janet Woodcock recuse herself from the review process for two generic versions of marketed anticoagulant Lovenox enoxaparin due to a conflict of interest. In its complaint, Amphastar cites four papers co-authored by Woodcock and scientists from Momenta Pharmaceuticals Inc. (NASDAQ:MNTA).

ANDAs for generic versions of enoxaparin from both Momenta and Amphastar are pending at FDA. Momenta partner Sandoz submitted its ANDA in 2005 and received a not-approvable letter in 2007 in which the agency said the application did not adequately address the potential for immunogenicity. Sandoz, the generics unit of Novartis AG (NYSE:NVS; SIX:NOVN), submitted a response to the letter last September. ...