US FDA grants tentative approval to Mylan's Sumatriptan Succinate tabs
The US FDA has granted tentative approval for Mylan Pharmaceuticals Inc.'s abbreviated new drug application for Sumatriptan Succinate tablets 25 mg (base), 50 mg (base) and 100 mg (base).
Sumatriptan Succinate tablets are indicated for the acute treatment of migraine headaches. They are the generic version of GlaxoSmithKline's Imitrex tablets, which had annual US sales of approximately $878 million as of March 31, 2006.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.