Zydus Lifesciences announced it has received final approvals from the USFDA for two generic drug formulations: Ivermectin Tablets USP, 3 mg, and Dapsone Tablets USP (25 mg and 100 mg). These approvals enable the company to market prescription anti-parasitic and anti-infective medications in the U.S. market. The Ivermectin product previously generated annual sales of USD 14.8 mn, while Dapsone generated USD 8.4 mn in the U.S. as of December 2025.
Zydus Secures Final USFDA Approvals
Zydus Lifesciences Limited confirmed on February 28, 2026, that it has received the final approvals from the United States Food and Drug Administration (USFDA) for two key generic products. The approved products are:
- Ivermectin Tablets USP, 3 mg (USRLD: Stromectol® Tablets, 3 mg)
- Dapsone Tablets USP, 25 mg and 100 mg (USRLD: Dapsone Tablets USP, 25 mg and 100 mg)
Therapeutic Applications and Market Value
The Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily used for treating parasitic worm infections, including intestinal strongyloidiasis and onchocerciasis. The annual sales for this drug in the United States were reported at USD 14.8 million.
The Dapsone Tablets USP (25 mg and 100 mg) are indicated for the treatment of leprosy and dermatitis herpetiformis, acting as an anti-infective and antibacterial agent. The combined annual sales for the Dapsone products in the U.S. reached USD 8.4 million (based on IQVIA MAT December 2025 data).
Manufacturing and Distribution
Both finished dosage forms will be manufactured at the group’s formulation manufacturing facilities in Ahmedabad. Specifically, Ivermectin tablets will be produced at the SEZ facility, while Dapsone tablets will be manufactured at the SEZ-II facility. Both products are slated for distribution in the United States by Viona Pharmaceuticals Inc.
Regulatory Milestones
This achievement contributes to the group’s ongoing regulatory success. The announcement noted that Zydus has now secured a total of 434 approvals and has filed 505* ANDAs since the commencement of the filing process in FY 2003-04. (*Data is accurate as on 31-Dec-2025.)
Source: BSE
