Parecoxib approval denied to Pfizer
While its competitor Merck faces a tough time in Atlantic City in the Humeston trial over Vioxx, Pfizer also received some bad news from the FDA. In a bold move, the Agency has denied approval to Dynastat (popular brand name for parecoxib sodium). Pfizer had applied for approval in December last year around the time Vioxx recall controversy was heating up and both Bextra and Celebrex were being investigated for serious side effects.
While Dynastat is being sold in other countries, since the safety of Cox-2 inhibitor drugs came under a cloud, there has been a lot of tough questioning of the firms. Australia has already banned Parecoxib. German authorities have already expressed their doubts about Dynastat. New Zealand has not yet banned Dynastat.
Pfizer makes Bextra that was banned by FDA in April this year. The other similar drug Celebrex from the company is now sold with a black box warning.
As expected, Pfizer does not agree with the FDA’s decision. “The company plans to meet with the FDA to discuss the agency’s concerns,” it said in a statement.
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