RMMS Defeats Motion for Preliminary Injunction Involving Generic Carbamazepine Extended-Release Capsules

July 6, 2011 | Small Molecules

07/06/2011 On July 6, 2011, the U.S. District Court for the District of New Jersey denied a motion for a preliminary injunction that would have blocked full generic competition for carbamazepine extended-release capsules. Nostrum Pharmaceuticals sought a preliminary injunction prohibiting FDA from approving otherwise eligible abbreviated new drug applications (ANDAs) for carbamazepine extended-release capsuleseven after patent expiration. The denial permits the FDA to approve eligible ANDAs for carbamazepine extended-release capsulesas Nostrum continues its case against FDA. Lara FitzSimmons, who argued for the firm’s client, William Rakoczy, Christine Siwik, and Eric Hunt handled the case for the firm’s client.