Teva Pharmaceutical Industries Ltd announced that the US Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline's Imitrex tablets, 25 mg, 50 mg and 100 mg for treatment of acute migraine attacks. Shipment of this product has commenced.
As one of the first companies to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Annual sales of this product were approximately $1 billion in the United States for the twelve months that ended December 30, 2008, based on IMS sales data.