Teva Pharmaceutical Industries on Wednesday announced the launch of generic Celebrex (celecoxib) capsules in the United States. The company is offering the capsules in 50-,100-, 200- and 400-mg dosage strengths.
Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.
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.
After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports.
A pair of Food and Drug Administration advisory committees will be meeting Feb. 10 to talk about heart risks associated with use of NSAIDs and whether or not Bayer's Aleve (naproxen) carries a lower risk profile than other NSAIDs