Ranbaxy Receives FDA Approval For All Strengths Of Sumatriptan

Ranbaxy has received final approval from FDA to manufacture and market Sumatriptan Succinate Tablets, 25mg (base) and 50mg (base). The Office of Generic Drugs, FDA, has determined Ranbaxy formulations to be bioequivalent and having the same therapeutic effect as that of the reference listed drug Imitrex by GlaxoSmithKline.

Bill Winter, vice president of Trade Sales in North America for 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.”

Ranbaxy Pharmaceuticals, based in Jacksonville, Florida, is a wholly-owned subsidiary of Ranbaxy Laboratories (RLL). RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.