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Cadila receives USFDA approval for acne drug

Zydus Cadila has received final approval to market minocycline hydrochloride extended release tablets, which is used for treating acne, from the US health regulator.

The drug which has received approval, is suggested for patients of 12 years of age or more, for treating only inflammatory lesions of non-modular moderate to severe acne vulgaris.

Cadila in a BSE filing stated, “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.”

The drug will be manufactured at company’s formulations manufacturing facility in Moraiya in Ahmedabad. Further, Cadila has also received tentative approval from the USFDA for the tablets in 55mg, 65mg and 115mg.

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