Zydus Cadila gets final FDA nod for skin disorder, hypertension drugs

Drug firm Zydus Cadila on Wednesday said it has received the final approvals from the US health regulator to market Desoximetasone ointment and Labetalol hydrochloride tablets.

While Desoximetasone ointment is used for treatment of symptoms of a skin disease, Labetalol hydrochloride tablets are used for the treatment of high blood pressure.

The approval from the United States Food and Drug Administration (USFDA) is to market Desoximetasone ointment USP, 0.25 per cent, Zydus Cadila said in a statement.

The drug will be manufactured at the group's topical manufacturing facility at Ahmedabad, it added.

"Desoximetasone ointment is used in relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses," Zydus Cadila said.

The group also received the final approval from the USFDA to market Labetalol hydrochloride tablets USP in the strengths of 100 mg, 200 mg, and 300 mg, it added.

The tablets are used to treat high blood pressure. The drug will be manufactured at the group's formulations manufacturing facility at the Pharma SEZ, Ahmedabad, Zydus Cadila said.

The group now has more than 150 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.

Shares of Cadila Healthcare, the company's listed entity were on Wednesday trading at Rs 487.10 per scrip in the afternoon trade on BSE, up 0.52 per cent from its previous close.