Ferring sues FDA to get five years of NCE exclusivity for Prepopik, and while FDA usually gets a great deal of judicial deference, Ferring may actually have precedent on its side.
Facing possible generic competition for Prepopik next month, Ferring Pharmaceuticals Inc. has filed suit against FDA seeking a court order to force the agency to rescind its denial of five years of market exclusivity for the fixed-dose combination product.
In a June 1 complaint filed in the U.S. District Court for the District of Columbia, Ferring challenges...
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
