Sun Pharmaceutical’s subsidiary gets USFDA approval for generic Uroxatral ER Tablets

19 Jul 2011 Evaluate

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.

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