Zydus Lifesciences has announced on Friday, May 23, that it has received final approval from the United States Food and Drug Administration (FDA) for its isotretinoin capsules USP in six dosage strengths: 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg.

The approved medication is a generic version of Absorica and is indicated for the treatment of severe, disfiguring nodular acne. The capsules will be manufactured at Zydus’ facility located in Moraiya, Ahmedabad.

According to IQVIA data (MAT March 2025), the annual market for isotretinoin capsules in the United States is estimated at $115.4 million.

This development marks another milestone for the pharmaceutical major, which has now secured a total of 427 final approvals and has filed 492 abbreviated new drug applications (ANDAs) since it began its US regulatory filings in FY2003-04.

The company stated that the approval reinforces its commitment to expanding its portfolio of dermatological treatments in key global markets.

Also Read: Belrise Industries IPO: GMP surges to ₹23 on final day of subscription