Objection, Your Honor: DOJ Appeals Court Order Lifting Plan B Age Limits

The high-profile battle over access to emergency contraception ramped up Wednesday with the Department of Justice (DOJ) appealing a federal court ruling that would mandate the FDA make TEVA’s Plan B One Step available without age restrictions by May 5. The appeal seeks a temporary stay of the judge’s order on the grounds that the court overstepped its bounds by mandating the FDA approve TEVA’s original ANDA without age restrictions.
Drug Industry Daily