Zydus Lifesciences Ltd on Thursday announced that it has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Tablets, used in the treatment of severe cystic acne.
The pharmaceutical company has been awarded the final approval for the Isotretinoin Capsules USP 10 mg, 20 mg 30 mg and 40 mg from the USFDA. The Reference Listed Drug (RLD) for this drug is Accutane Capsules 10 mg, 20 mg and 40 mg, the company said in a filing to the stock exchanges.
The aforementioned tablets are recommended for the treatment of severe cystic acne, which is also known as nodular acne. The capsules are used when none of the other treatments have worked, for example, applying benzoyl peroxide or clindamycin to the skin, or taking tetracycline or minocycline orally.
As per Section 505-1 of the United States Federal Food, Drug, and Cosmetic Act (FD&C Act), the company needs to submit a Risk Evaluation and Mitigation Strategy (REMS) for the manufacturing of Isotretinoin Tablets.
Zydus Lifesciences has informed the bourses, that the USFDA has approved its proposed REMS on the aforementioned drug, adding that the company’s ‘Isotretinoin iPLEDGE REMS’ contains Elements to Assure Safe Use (ETASU), along with an implementation system.
As per IQVIA MAT data for July 2023, the Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg had annual sales worth $165 million in the United States.
So far, Zydus Lifesciences has received a total of 378 approvals and has filed more than 444 Abbreviated New Drug Applications (ANDA) (as of June 30, 2023) since the process of filing started in FY 2003-04.
Shares of Zydus Lifesciences were trading 0.36 percent lower at Rs 625.9 per piece on BSE at 3:10 PM on Thursday.
(Edited by : Asmita Pant)
