FDA's "not approvable" letter for Pharmacia's injectable COX-2 inhibitor parecoxib "has no implications" for valdecoxib review, McKinnell says. "These are separate NDAs, separate clinical studies...We're very well satisfied that valdecoxib meets the FDA standards" for safety and efficacy. The NDA for valdecoxib (oral active moiety of the prodrug parecoxib) was filed Jan. 1 for rheumatoid arthritis, osteoarthritis, dysmenorrhea and acute pain
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