Zydus Lifesciences Gets USFDA Nod for Generic Absorica to Treat Severe Acne

24 May 2025 , 08:15 PM

Zydus Lifesciences has received final approval from the USFDA to launch its isotretinoin capsules USP in six different strengths.  The approval includes six different strengths 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg. It allows physicians to choose the most appropriate dose based on each patient’s individual needs.

They are the generic form of Absorica, a well-known prescription treatment for severe and hard to treat forms of nodular acne that the patient has not responded well to other treatments with.

The product will be manufactured at the group’s plant in Moraiya, Ahmedabad, ensuring that the U-3HALEU API is delivered with global quality standards and complies with the company’s commitment to develop high-quality, export-ready manufacturing from India.

With this approval, Zydus has so far received 427 final approvals and is currently… competing in the US $ 64.9 billion (as per IQVIA MAT June 2019) and growing U.S. generics market. The company now has a total of 492 ANDA approvals (including 19 tentative approvals) from USFDA since it started filing in FY2003-04.

This approval demonstrates our continuing commitment to providing affordable skincare solutions to global markets, Zydus said. The company is expanding its product portfolio in dermatology and other critical therapeutic areas and expects to continue seeking new Global partners who can help the company fulfill its mission to supply globally to market and suit patient needs.