When the U.S. Food and Drug Administration approves a new drug, it also approves a package insert of the drug, known as a “product label.” A pharmaceutical company marketing a generic product is required to package their...more
On December 3, 2014, the Federal Circuit issued a decision in Par Pharmaceutical, Inc. and Alkermes Pharma Ireland Limited v. TWI Pharmaceuticals, Inc., agreeing with the district court’s analysis and conclusions on...more