Viatris Sues Teva In US Over ‘Illegal Copaxone Scheme’
New Jersey Lawsuit Alleges ‘Series Of Tactics’ By Teva
Viatris’ Mylan has accused Teva of creating a perfect ‘playbook’ to delay Mylan’s launch of a generic version of its Copaxone blockbuster and then strangle uptake, something Mylan was vocal about years earlier, in a suit filed in a New Jersey court.
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Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.
US FDA’s interpretation of ‘protein’ is reasonable and owed deference, the court concludes in tossing Teva suit which challenged Copaxone’s exclusion from list of drugs transitioned to being regulated as biologics.
Fresh from a $20m investment from partner Viatris, Mapi Pharma has announced significant progress in its Phase III trial for a long-acting version of Copaxone, which is to be filed through the FDA’s 505(b)(2) hybrid pathway.