Zydus Lifesciences Limited has announced receiving final approvals from the United States Food and Drug Administration (USFDA) for two generic pharmaceutical products on February 28, 2026. The approvals encompass Ivermectin Tablets USP, 3 mg and Dapsone Tablets USP in both 25 mg and 100 mg strengths, expanding the company's presence in the US generic drug market.

Product Details and Market Potential

The approved products target significant therapeutic areas with established market demand:

Therapeutic Applications

Ivermectin Tablets

Ivermectin Tablets USP, 3 mg serve as prescription anti-parasitic medications with primary indications for treating parasitic worm infections in humans. The drug specifically targets intestinal strongyloidiasis and onchocerciasis, representing the US reference listed drug Stromectol® Tablets, 3 mg.

Dapsone Tablets

Dapsone Tablets USP in 25 mg and 100 mg strengths are indicated for treating leprosy in all forms, including multibacillary and paucibacillary variants, as well as dermatitis herpetiformis. The medication functions as an anti-infective and antibacterial agent, effectively controlling skin lesions associated with dermatitis herpetiformis and managing leprosy symptoms.

Manufacturing and Distribution Strategy

Both pharmaceutical products will be manufactured at Zydus Lifesciences Limited 's formulation manufacturing facilities in Ahmedabad. Ivermectin tablets will be produced at the SEZ facility, while Dapsone tablets will be manufactured at the SEZ-II facility. Distribution for both products will be handled through Viona Pharmaceuticals Inc.

Regulatory Portfolio Expansion

With these latest approvals, the company has strengthened its regulatory portfolio significantly:

*As on December 31, 2025

The combined annual sales potential of USD 23.2 million for both products, based on IQVIA MAT December 2025 data, represents a meaningful addition to the company's US market opportunities. These approvals demonstrate Zydus Lifesciences' continued commitment to expanding its generic pharmaceutical offerings in specialized therapeutic segments.

Zydus Lifesciences has achieved a major milestone in biosimilar development by successfully completing the pivotal Dahlia pharmacokinetic study for FYB206, a pembrolizumab biosimilar that demonstrates bioequivalence to the reference product Keytruda.

Pivotal Study Success

The company announced that the randomized, double-blind, multi-centre clinical PK study successfully met its primary study objective, demonstrating pharmacokinetic equivalence of FYB206 with Keytruda. This achievement represents the completion of the clinical data package required for regulatory submission.

Strategic Partnership and Market Access

Zydus has in-licensed FYB206 exclusively from Formycon AG for the U.S. and Canadian markets. The successful study completion positions the company as a potential first-wave filer in the North American immuno-oncology biosimilar market.

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated: "The positive clinical data for the FYB206 marks a key milestone in our collaboration with Formycon and reflects our shared commitment to expand access to affordable, life-saving oncology treatments. FYB206 represents the absolute cornerstone of our strategic entry into the complex North American immuno-oncology market."

Regulatory Pathway and Market Potential

With the clinical data package effectively complete, this achievement clears the pathway for a near-term Biologics License Application (BLA) filing with the USFDA. At the beginning of 2025, Formycon and the FDA had agreed on a streamlined clinical strategy to demonstrate therapeutic comparability of FYB206 with Keytruda.

Pembrolizumab is a humanized monoclonal antibody used to treat various tumors, and Keytruda is currently one of the world's best-selling drugs with global sales of US$ 31.60 billion in 2025, underscoring the substantial market potential.

Company Profile

Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, with a global footprint across the United States, India and other international markets.

Source: None/Company/INE010B01027/e8f76a26-0258-44c9-aa02-2cf8b5cb45d6.pdf