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Actavis sues FDA for delaying approval of generic Celebrex.

M2 PHARMA-May 1, 2014-Actavis sues FDA for delaying approval of generic Celebrex

(C)2014 M2 COMMUNICATIONS

Actavis, an integrated speciality pharmaceutical company with offices in Dublin, Eire, and New Jersey, USA, has announced that its subsidiary, Watson Laboratories, has filed a law suit against the US Food and Drug Administration (FDA) over its decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex (celecoxib) 50mg, 100mg, 200mg and 400mg capsules, it was reported yesterday.

In Actavis's opinion, the FDA improperly awarded sole exclusivity on generic Celebrex to Teva Pharmaceutical Industries, which conflicted with an earlier ruling from the US Court of Appeals for the Federal Circuit that resulted in the triggering and subsequent expiration of Teva's sole exclusivity on the product.

Actavis is seeking a judgment from the US District Court for the District of Columbia, declaring that the FDA decision is arbitrary, capricious and contrary to law, The company is also entering an injunction directing the FDA to approve its ANDA for generic Celebrex no later than the same date that the first ANDA for a generic version of Celebrex is approved.

Actavis is also asking the Court to issue an injunction granting a 180-day exclusivity period for generic Celebrex to Actavis as a first filer of a substantially complete ANDA containing a Paragraph IV certification to US Patent No. RE44,048.

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Publication:M2 Pharma
Date:May 1, 2014
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