FDA Cites Immunogenicity Concerns In “Not Approvable” Letter For Momenta/Sandoz’s Lovenox Generic
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm is “confident” no immunogenicity differences will arise, Momenta CEO Wheeler says.
You may also be interested in...
Safety Data Keeps Momenta/Sandoz’ Generic Lovenox In Play With FDA
Response to immunogenicity concern could boost chances for FDA approval next year.
Safety Data Keeps Momenta/Sandoz’ Generic Lovenox In Play With FDA
Response to immunogenicity concern could boost chances for FDA approval next year.
Lovenox ANDA Approval In 2008 Is “Not Out Of Reach,” Momenta CEO Wheeler Says
Chief exec optimistic that FDA will not require any additional clinical trials to move filing forward.