US FDA clears Teva's generic Imitrex
The US Food and Drug Administration has granted final approval for Isaeli drugmaker Teva Pharmaceutical Industries' Abbreviated New Drug Application to market its generic version of GlaxoSmithKline's Imitrex (sumatriptan) tablets, 25mg, 50mg and 100mg for treatment of acute migraine attacks. Shipment of this product has commenced, says Teva.
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 the GSK product were around $1.0 billion in the USA for the 12 months ended December 30, 2008, based on IMS sales data.
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