New Delhi: Sun Pharmaceutical Industries on Tuesday said it has received the US health regulator’s nod to market Alfuzosin Hydrochloride tablets, used in the treatment of prostatic hyperplasia, in the American market.
The company’s subsidiary has received approval from the US Food and Drug Administration (USFDA) to market Alfuzosin Hydrochloride extended release tablets - a generic version of Uroxatral ER - in strengths of 10 mg, Sun Pharma said in a statement.
“Sun Pharma, being the first-to-file an abbreviated new drug application (ANDA) for generic Uroxatral ER with a para IV certification, received 180-day marketing exclusivity,” it added.
The company’s Alfuzosin Hydrochloride 10-mg tablets are therapeutically equivalent to drug-maker Sanofi-Aventis’ Uroxatal extended release tablets, it said.
Alfuzosin Hydrochloride extended release tablets, which are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia, have annual sales of nearly $250 million in the US, it added.
Shares of Sun Pharma were being quoted at Rs 509 apiece on the Bombay Stock Exchange in late afternoon trade today, up 1.67% from their previous close.