FDA grants marketing approval of ANDA for enoxaparin sodium for injection

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application (ANDA) for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this product has been designated therapeutically equivalent to the reference-listed drug, Lovenox®, which is marketed by Sanofi-Aventis.  

"The approval of M-Enoxaparin marks a key milestone for Momenta, and we are extremely pleased," commented Craig Wheeler, President and CEO. "This is the first product based on Momenta's technology platform to be approved, and demonstrates our ability to characterize and develop a complex mixture drug like Lovenox."

The Company is aware that other ANDAs for enoxaparin sodium injection have been filed. These other applicants may receive approval at a later date.