Celebrex Generic Exclusivity Suit Could Have Broad Financial, Regulatory Reach
Appeals court says FDA violated Hatch-Waxman by awarding 180-day exclusivity solely to Teva based on reissued patent; celecoxib generics are already marketed but could step out from Pfizer-authorized status.
You may also be interested in...
Patent Regulation Drops Deference To ANDA, 505(b)(2) Sponsors
FDA's final rule implementing provisions of Medicare Modernization Act ‘will fuel litigation,’ attorney predicts.
Par Fights FDA Forfeiture Of Generic Colcrys Exclusivity
Pursing legal action against the agency in an area where it is sometimes vulnerable, Par argues that amending its proposed label did not interrupt paragraph IV certification for the firm's colchicine ANDA.
At Tofersen Panel Review, US FDA Shined A Light On Internal Differences Of Opinion
Agency’s presentations on Biogen/Ionis’ ALS drug included differing viewpoints from the statistical and clinical pharmacology teams; the transparency and emphasis on a multidisciplinary review approach may reflect lessons learned from missteps at the Aduhelm panel review in 2020.