In a significant development, Zydus Lifesciences Ltd announced on Thursday that it has secured final approval from the US Food and Drug Administration (USFDA) to introduce its generic version of Dapsone gel, a widely used treatment for acne.
The regulatory nod covers the generic version of Dapsone gel with a potency of 7.5 percent, as confirmed by Zydus Lifesciences in a regulatory filing. Dapsone gel is renowned for its efficacy in treating acne, and the approval marks a milestone for Zydus Lifesciences in its commitment to delivering affordable and accessible healthcare solutions.
Manufactured at the group’s topical manufacturing facility in Changodar, Ahmedabad, the Dapsone gel is poised to address the growing demand for acne treatment options in the US market. According to Zydus Lifesciences, the annual sales of Dapsone gel, 7.5 percent, in the US amounted to a substantial $35.8 million, based on IQVIA MAT March 2024 data.
The approval from the USFDA underscores Zydus Lifesciences’ dedication to adhering to stringent quality standards and regulations, ensuring the safety and efficacy of its pharmaceutical products. With this latest approval, Zydus Lifesciences strengthens its position in the global pharmaceutical market and reaffirms its commitment to advancing healthcare accessibility and affordability.
Zydus Lifesciences Ltd is a leading pharmaceutical company dedicated to improving global healthcare through innovative and affordable pharmaceutical solutions. With a focus on research, development, and manufacturing, Zydus Lifesciences is committed to addressing unmet medical needs and enhancing patient outcomes worldwide.
