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Teva gets US FDA tentative nod for sumatriptan succinate tabs

Jerusalem, IsraelFriday, December 1, 2006, 08:00 Hrs  [IST]

Teva Pharmaceutical Industries Ltd. announced today that the US Food and Drug Administration has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate tablets, 25 mg, 50 mg and 100 mg. Final approval is expected upon expiry of patent protection for the brand product in February 2009. Upon final approval, Teva's Sumatriptan Succinate tablets will be the AB-rated generic equivalent of GlaxoSmithKline's Imitrex tablets, indicated for acute treatment of migraine headaches. The brand product had annual sales of approximately $910 million for the twelve months ended September 2006, based on IMS sales data.

 
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