Zydus Receives Final Approval From The USFDA For Isotretinoin Capsules

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as Zydus) has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg, the company on Thursday announced through an exchange filing.

About Isotretinoin Capsules

Isotretinoin Capsules is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (such as benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth).

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 million in the United States. 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.

Zydus Lifesciences Limited shares

The shares of Zydus Lifesciences Limited on Thursday at 1:31 pm IST were at Rs 625.05, down by 0.49 percent.