Teva given tentative approval for Sumatriptan Succinate tablets

Published: 30-Nov-2006
Regulatory

The US FDA has granted tentative approval for Teva Pharmaceutical Industries" 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.


The US FDA has granted tentative approval for Teva Pharmaceutical Industries" 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 US$910m for the 12 months ended September 2006, based on IMS sales data.

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