Zydus Cadila gets USFDA approval for acne drug

New Delhi: Zydus Cadila has received final approval from the US health regulator to market minocycline hydrochloride extended-release tablets used to treat acne.

The company has got final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 45 mg, 80 mg, 90 mg, 105 mg and 135 mg, Zydus Cadila said in a BSE filing.

It has also received tentative approval from the regulator for the tablets in 55 mg, 65 mg, and 115 mg.

The company will produce the drug at its formulations manufacturing facility in Moraiya in Ahmedabad.

Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-modular moderate to severe acne vulgaris in patients of 12 years of age or older.

The company has more than 170 approvals and so far filed over 310 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.