Zydus Lifesciences bags FDA final approval for generic of acne medication

Zydus Lifesciences has received the final approval from the US Food and Drug Administration (FDA) for Minocycline Hydrochloride Extended-Release Tablets in 55 mg, 65 mg, and 115 mg strengths.

The tablets, which are the generic version of Solodyn Tablets, are used to treat moderate to severe acne in individuals aged 12 years and above.

The acne medication, which belongs to a class of drugs known as tetracycline antibiotics, will be produced at Zydus’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Zydus Lifesciences secures FDA final approval for Minocycline Hydrochloride Extended-Release Tablets, generic of acne medication. Photo courtesy of Zydus Cadila.

“Minocycline Hydrochloride Extended-Release Tablets USP, 55 mg, 65 mg, and 115 mg” recorded annual sales of $0.7 million in the United States, as per IQVIA MAT’s April 2023 report.

This approval strengthens Zydus Lifesciences’ position in the market, bringing its total approvals to 372. The company has filed more than 442 abbreviated new drug applications (ANDAs) since the beginning of the filing process in the financial year 2003-04.