Ranbaxy wins FDA approval for generic migraine drug

Wed. August 12, 2009; Posted: 12:01 PM

Aug 12, 2009 (Datamonitor via COMTEX) -- RBXLF | Quote | Chart | News | PowerRating -- Indian pharmaceutical company Ranbaxy Laboratories has received final approval from FDA to manufacture and market sumatriptan succinate tablets, 25mg, and 50mg.

The Office of Generic Drugs, FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Imitrex by GlaxoSmithKline.

According to Ranbaxy, sumatriptan succinate 25mg and 50mg tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.

Bill Winter, vice president of trade sales for North America at Ranbaxy, said: "We are pleased to receive this final approval for sumatriptan succinate tablets 25mg and 50mg in addition to the 100mg that was previously approved. This FDA approval represents the sixth such authorization to commercialize product to be granted by the agency so far in 2009.

"This product will be launched immediately to all classes of trade and further expands our product portfolio of affordable generic product formulations, that will be of benefit to patients, healthcare professionals and the US healthcare system."

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