FDAnews Drug Daily Bulletin

Sanofi-Aventis is asking a federal judge to issue an injunction blocking the sale of a generic version of Lovenox on the grounds that the FDA improperly approved the ANDA. “By approving Sandoz’s ANDA, FDA has exceeded its authority under Section 505(j) of the [Food, Drug and Cosmetics Act], ignored its own precedent regarding approval of generic versions of drugs that have not been fully characterized, and has failed to ensure that Sandoz’s drug has the same active ingredient as Lovenox,” the company’s complaint in the U.S. District Court for the District of Columbia states.
Drug Industry Daily