Ranbaxy gets tentative FDA approval for tamsulosin formulation

06/22/07 - newratings.com

NEW YORK, June 22 (newratings.com) - Ranbaxy Laboratories Ltd (RLYG) Friday announced that its tamsulosin hydrochloride capsules had received tentative approval from the US Food and Drug Administration (FDA).

The Indian pharmaceutical research and manufacturing company said tamsulosin is the generic equivalent of Flomax, which is made by Japan’s Astellas Pharma Inc. The medicine is used in the treatment of benign prostatic hyperplasia. Ranbaxy Laboratories said the US market for Flomax was $1.1 billion. The company added that it hoped to introduce the formulation with a 180-day exclusivity period, if the patent litigation is successful.