Zydus Lifesciences receives USFDA approval for Ivermectin and Dapsone tablets

Zydus Lifesciences Ltd announced that  it has received final approvals from the United States Food and Drug Administration for Ivermectin Tablets USP, 3 mg, and Dapsone Tablets USP, 25 mg and 100 mg.

The company in a press release stated that Ivermectin Tablets USP, 3 mg, are the generic equivalent of the Reference Listed Drug  Stromectol® Tablets, 3 mg, while Dapsone Tablets USP, 25 mg and 100 mg, reference the USRLD Dapsone Tablets USP, 25 mg and 100 mg.

According to the press release, Ivermectin is a prescription anti-parasitic medication indicated for treating parasitic worm infections in humans, specifically intestinal strongyloidiasis and onchocerciasis. 

The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad, and will be distributed by Viona Pharmaceuticals Inc. Zydus, citing IQVIA data for the moving annual total (MAT) ending December 2025, noted that Ivermectin Tablets USP, 3 mg, had annual sales of $14.8 million.

Dapsone is indicated for the treatment of leprosy, encompassing all forms including multibacillary and paucibacillary, and dermatitis herpetiformis. It acts as an anti-infective and antibacterial agent used to control skin lesions in dermatitis herpetiformis and for leprosy. 

The company specified that Dapsone tablets will be produced at the group’s formulation manufacturing facility at SEZ-II, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. Dapsone Tablets USP, 25 mg and 100 mg, recorded annual sales of $8.4 million in the US according to IQVIA data (MAT December 2025).

The group now has 434 final approvals and has filed 505 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in 2003-04, as of December 31, 2025.