US Ruling Confirms Copaxone Is Not A Biologic

Legal Fight May Finally Be Over After District Court Ruling

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.

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District court dismisses Teva's suit against FDA over Copaxone designation • Source: Shutterstock

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