Ranbaxy Laboratories Limited (Ranbaxy), announced yesterday that the Company has received final approval from the U.S. Food and Drug Administration to manufacture and market Sumatriptan Succinate Tablets, 25 mg (base), and 50 mg (base). The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Imitrex® by GlaxoSmithKline. Total annual market sales for Sumatriptan Succinate 25 mg and 50 mg tablets were $379 million (IMS – MAT: June 2009) which is indicated for the acute treatment of migraine attacks with or without aura in adults.
“We are pleased to receive this final approval for Sumatriptan Succinate Tablets 25 mg and 50 mg in addition to the 100 mg 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 U.S. healthcare system,” according to Bill Winter, Vice President, Trade Sales, North America.
