Mylan challenges FDA ruling on celecoxib

PITTSBURGH — 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.

Mylan believes that the agency was misguided in its decision in the case and maintains that it is in a position to receive final approval on May 30 when Celebrex's remaining patents expire. Other companies have settled for a December 2014 launch date and will be unable to launch on May 30.

"We believe the FDA has made an unprecedented error in this case which clearly caught all industry participants off guard, as evidenced by some who have already settled with Pfizer for December 2014 launch dates, which is post patent expiry. Mylan seeks an order compelling FDA to grant final approval of Mylan's ANDA on May 30, 2014," said Heather Bresch, Mylan CEO.


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