Zydus Lifesciences gets USFDA nod for generic acne-treating drug
The approval granted by the US Food and Drug Administration (USFDA) is for Minocycline Hydrochloride extended-release tablets of strengths 55 mg, 65 mg, and 115 mg, Zydus Lifesciences said in a regulatory filing.
Zydus Lifesciences on Monday said it has received final approval from the US health regulator for its generic antibiotic Minocycline Hydrochloride extended-release tablets used for treatment of moderate to severe acne.
The approval granted by the US Food and Drug Administration (USFDA) is for Minocycline Hydrochloride extended-release tablets of strengths 55 mg, 65 mg, and 115 mg, Zydus Lifesciences said in a regulatory filing.
The tablet is used for treatment of moderate to severe acne in people aged 12 years and above.
The product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, the company said.
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