India's Ranbaxy gets tentative U.S. nod for tamsulosin
India's Ranbaxy Laboratories Ltd. said on Friday it has received tentative approval from the U.S. Food and Drug Administration for its tamsulosin hydrochloride capsules.
Tamsulosin, a generic equivalent of Flomax, is used to treat benign prostatic hyperplasia. Annual U.S. sales for Flomax were $1.1 billion, Ranbaxy said in a statement.
We anticipate introducing this formulation with a 180-day period of exclusivity assuming the successful resolution of the patent litigation, said Jim Meehan, vice president of sales and marketing, Ranbaxy Pharmaceuticals Inc., a wholly-owned unit.
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