Mylan challenges FDA ruling on exclusivity relating to generic celecoxib

US generics firm Mylan (Nasdaq: MYL) has filed suit against the US Food and Drug Administration, challenging the agency's decision regarding generic drug marketing exclusivity on celecoxib capsules, the generic version of US pharma giant Pfizer's (NYSE: PFR) Celebrex.

The FDA issued a decision holding that eligibility for 180 days of exclusivity is only available to an applicant who first filed a Paragraph IV certification to an original patent and who then also made a timely PIV certification to a reissued patent, despite an earlier appellate court decision that held the original patent invalid, and a subsequent decision holding the reissued patent invalid.

Believes it is eligible for final FDA approval on May 30