Zydus Lifesciences receives USFDA approval for severe cystic acne drug Isotretinoin

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Section 505-1 of the FD&C Act authorizes FDA to require the submission of a Risk Evaluation and Mitigation Strategy (REMS) for this product. Zydus’ proposed REMS has also been approved by FDA. The Isotretinoin iPLEDGE REMS consists of Elements to Assure Safe Use (ETASU) and an implementation system.

Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg had annual sales of USD 165 mn in the United States (IQVIA MAT July 2023).

The group now has 378 approvals and has so far filed over 444* ANDAs since the commencement of the filing process in FY 2003-04.

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Medical Dialogues team had earlier reported that the company had received final approval from the USFDA for Minocycline Hydrochloride Extended-Release Tablets USP, 55 mg, 65 mg, and 115 mg (USRLD: Solodyn Tablets, 55 mg, 65 mg, and 115 mg).

Read also: Acne drug: Zydus Lifesciences bags USFDA nod for Minocycline Hydrochloride ER tablets