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Momenta Pharmaceuticals Announces FDA Approval and Launch of Glatopa
Feb. 13, 2018 09:12AM PST
Pharmaceutical InvestingMomenta Pharmaceuticals (Nasdaq:MNTA) today announced that the U.S. Food and Drug Administration (FDA) has approved Sandoz’s Abbreviated New Drug Application for Glatopa (glatiramer acetate injection) 40 mg/mL and that Sandoz has initiated the launch of this product in the US. Glatopa was developed under a collaboration agreement between Momenta and Sandoz and is produced in …
Momenta Pharmaceuticals (Nasdaq:MNTA) today announced that the U.S. Food and Drug Administration (FDA) has approved Sandoz’s Abbreviated New Drug Application for Glatopa (glatiramer acetate injection) 40 mg/mL and that Sandoz has initiated the launch of this product in the US. Glatopa was developed under a collaboration agreement between Momenta and Sandoz and is produced in the US.
As quoted in the press release:
“This approval further validates the strength of our physicochemical and biological characterization capabilities,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We are very proud to once again be able to provide patients with relapsing-forms of MS with a cost effective, high-quality generic alternative treatment option.”
