Mylan and Actavis contest Teva’s generic celecoxib exclusivity
The US Food and Drug Administration (FDA) has approved the first batch of generic competitors to Pfizer’s non-steroidal anti-inflammatory Celebrex (celecoxib). Teva received approval for its 50, 100, 200 and 400mg doses, and Mylan also had its 50mg dose approved. Actavis, which was also in the running, is yet to receive final approval for any of its celecoxib generics.
The agency has also granted Teva 180 days’ market exclusivity for all but the 50mg form, under US provisions designed to encourage generic competition. Both Mylan and Actavis have attempted to sue the FDA for this decision, which Mylan has called an ‘unprecedented error’ and Actavis described in a statement as ‘arbitrary, capricious and contrary to law’. The court denied Mylan’s injunction, but the company has signalled its intention to appeal that decision.