Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries has announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Uroxatral ER, alfuzosin hydrochloride extended release tablets.

Sun Pharma, being the first-to file an ANDA for generic Uroxatral ER with a para IV certification, received a 180 day marketing exclusivity. These alfuzosin hydrochloride 10 mg tablets are therapeutically equivalent to Uroxatal Extended Release tablets from sanofi-aventis. Alfuzosin hydrochloride extended release tablets have annual sales of approximately $250 in the US.

Alfuzosin is an alpha 1 blocker for the treatment of signs and symptoms of benign prostatic hyperplasia.

Recently, the company’s subsidiary received an approval from USFDA for its abbreviated new drug application (ANDA) to market a generic version of Sumatriptan Succinate Injection, 6 mg (base) / 0.5 mL. This is the first ANDA approval for a Sumatriptan AutoInjector.

Sun Pharmaceutical Industries manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.