New Delhi: Drug firm Unichem Laboratories has received approval from the US health regulator to market alfuzosin hydrochloride extended release tablets, used in treating prostatic hyperlasia, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) for alfuzosin hydrochloride extended release tablets, a generic version of Concordia Pharmaceuticals Ins’s Uroxatral extended release tablets, Unichem Laboratories said in a regulatory filing.
The tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperlasia in adults.
“The product will be commercialised from Unichem’s Goa plant. The active pharmaceutical ingredients (API) for the product would also be made in-house at Pithampur plant,” the company said.
Unichem now has a total of 20 abbreviated new drug application (ANDA) approvals from the USFDA.