• Regulatory NewsRegulatory News

    FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics

    The US Food and Drug Administration (FDA) on Wednesday denied Allergan's third citizen petition attempting to block the agency from approving generic versions of the company's blockbuster Restasis (cyclosporine ophthalmic emulsion). "This is Allergan's third petition concerning the methods an ANDA [abbreviated new drug application] applicant might use to demonstrate that a proposed generic drug is bioequivalent to Restasis. As in its previous petitions and commen...
  • Regulatory NewsRegulatory News

    Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement

    In a setback for Allergan, four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday by the US District Court for the Eastern District of Texas. Allergan has said it will appeal the decision, but what might have a wider ripple effect was another order that raised questions about Allergan’s decision to transfer the patents to a Native American tribe to prolong the launch of Restasis generics. In the order on the agreement ...