Approval for generic copaxone - yes, finally:
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Now - DJNF
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
-- First generic multiple sclerosis product approved in the United States
-- Approval triggers $10 million milestone payment to Momenta
CAMBRIDGE, Mass., April 16, 2015 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that the U.S. Food and Drug Administration has granted marketing approval of Sandoz's Abbreviated New Drug Application for once daily Glatopa(TM) (glatiramer acetate injection, formerly M356) 20 mg/mL, a generic equivalent of daily COPAXONE(R) 20 mg. Glatopa is the first substitutable generic indicated for the treatment of patients with relapsing-forms of multiple sclerosis (RRMS), a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. Glatopa was developed under a collaboration agreement between Momenta and Sandoz and is the second complex generic developed by Momenta together with Sandoz to receive FDA approval. Glatopa will be commercialized under the Sandoz brand.
"We are proud to be able to offer patients with multiple sclerosis the first generic version of daily COPAXONE and the first generic product in this space," said Craig Wheeler, President and CEO, Momenta Pharmaceuticals. "The FDA approval of the ANDA for once daily Glatopa further validates Momenta's approach of using innovative physicochemical and biologic characterization to gain approval of complex generics, biosimilars and novel drugs, and advances Momenta's goal of expanding access to high quality, more affordable medicines."
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