Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, announced that the United States District Court for the District of Columbia denied sanofi-aventis U.S. LLC’s request for a preliminary injunction directing the FDA to suspend and withdraw its approval of the Abbreviated New Drug Application (ANDA) filed by the Company’s collaboration partner, Sandoz, for enoxaparin sodium injection USP, a generic version of Lovenox. The decision is subject to appeal.
“We continue to believe that the FDA engaged in a thorough review of the science supporting the Sandoz enoxaparin sodium injection ANDA, and are pleased that the Court re-affirmed the validity of the FDA’s decision,” stated Craig Wheeler, President and Chief Executive Officer of Momenta. “Sandoz commenced shipping of enoxaparin sodium injection following the FDA’s marketing approval of Sandoz’s ANDA on July 23, 2010.”
The suit was filed on July 27, 2010 in the United States District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA), Margaret A. Hamburg, Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services.
Sandoz intervened in the case, and filed an opposition to the sanofi-aventis request. Momenta has worked closely with Sandoz to support the FDA in defending the suit.
On July 23, 2010, the U.S. Food and Drug Administration granted marketing approval of Sandoz’s ANDA for enoxaparin sodium injection as an AP-rated generic equivalent of sanofi-aventis’ Lovenox.
Date: August 25, 2010
Source: Momenta Pharmaceuticals, Inc.
Filed Under: Drug Discovery