Momenta Pharmaceuticals, Inc. (MNTA)

[pollyvonwog]

Momenta Pharmaceuticals Announces Abbreviated New Drug Application for Three-Times-a-Week Generic Copaxone Accepted for Review by FDA



CAMBRIDGE, Mass., Aug. 28, 2014 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals (Nasdaq:MNTA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for a three-times-a-week generic COPAXONE® (glatiramer acetate injection, 40 mg/mL), submitted by Sandoz Inc., Momenta's development and commercialization partner for this product candidate.

Based on publicly-available information, Momenta believes that, should the ANDA be approved, it would be eligible for 180-day first-to-file exclusivity under Hatch-Waxman. The product could be on the market as early as the first quarter of 2017, assuming the Paragraph IV challenge is successful and adheres to customary Hatch-Waxman litigation timelines. Since the 40 mg/mL formulation contains the same drug substance as the 20 mg/mL ANDA currently under review by the FDA, Momenta anticipates the FDA review process can be completed within the same time frame.

"We are pleased to announce the acceptance of the ANDA for our three-times-a-week generic Copaxone for revi