Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.
Mylan last week announced that it filed suit against the Food and Drug Administration, challenging the agency's decision regarding generic drug marketing exclusivity on celecoxib capsules, the generic equivalent of Pfizer's Celebrex.
Teva Pharmaceutical announced that its U.S. subsidiary has entered into a settlement with Pfizer related to Teva's generic version of Celebrex (celecoxib) 50-, 100-, 200- and 400-mg capsules in the United States.
A large new observational study published Friday found more evidence of an association between daily aspirin use and modestly lower cancer mortality, but suggested any reduction may be smaller than that observed in a recent analysis. The study appeared online in the Journal of the National Cancer Institute.