Thursday, August 28, 2014 9:32:51 AM
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
Lingerie Fighting Championships Signs Broadcast Deal With Maybacks Global Entertainment • BOTY • Sep 26, 2024 9:00 AM
Maybacks Global Entertainment and Lingerie Fighting Championships Enter Into Broadcast And Revenue Sharing Agreement • AHRO • Sep 26, 2024 8:30 AM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM