US rejects Pfizer’s injectable Cox-II

pharmafile | September 22, 2005 | News story | Sales and Marketing |   

The FDA has denied approval for Pfizer's injectable pain drug Dynastat, delivering a fresh blow to the embattled Cox-II class of drugs.

Pfizer received a non-approvable letter from the US regulators but said it disagreed with the decision and planned to meet the FDA to discuss its concerns.

The injectable Cox-II has been available across Europe for a number of years, but now carries specific warnings about rare side-effects observed in some patients.

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Pfizer issued a brief statement following the FDA's rejection, saying that Dynastat (parecoxib sodium) represents an important option for physicians in the treatment of acute pain following surgery.

Furthermore, the US company contrasted the FDA's ruling with that of the EMEA, which allowed the continued marketing of Dynastat following a review of the entire Cox-II class.

Pfizer had hoped Dynastat would claw back some of the sales losses felt by the withdrawal of Bextra, which generated $1.3 billion in sales last year.

The FDA requested Bextra's withdrawal from the market after concluding that a new appraisal of its benefit/risk profile required its suspension.

Pfizer has also withdrawn the drug across Europe but said it is maintaining dialogue with authorities to see if it can be returned to the market.

Related articles:

Bextra withdrawal dents Pfizer's sales juggernaut 

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