Unichem Laboratories gets USFDA's nod to market generic labetalol hydrochloride tablets

Unichem Laboratories Ltd on Tuesday said it has received approval from the US health regulator to market its generic version of labetalol hydrochloride tablets used to treat high blood pressure.

The approval granted by the US Food and Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of labetalol hydrochloride tablets of strengths 100 mg, 200 mg, and 300 mg, the company said in a regulatory filing.

These are the generic equivalent of Normodyne tablets of 100 mg, 200 mg, and 400 mg of Schering Corp.

The tablets will be produced at the company's Goa plant, Unichem said.