Zydus Lifesciences receives final approval from the USFDA for Dapsone Gel

As per reports, on May 9th, 2024, Zydus Lifesciences Ltd received final approval from the US FDA to market its generic Dapsone gel, a treatment for acne, a common skin condition characterized by pimples or "zits." These manifestations include whiteheads, blackheads, and red, inflamed patches of skin known as cysts.

Dapsone Gel, classified as a sulfone antibiotic, operates by slowing or halting bacterial growth, thereby reducing inflammation associated with acne. It suits individuals across various age groups, including children, teenagers, and adults.

Zydus Lifesciences disclosed in a regulatory filing that the US Food and Drug Administration (USFDA) has granted final approval for Dapsone gel, formulated at a strength of 7.5 percent. This gel addresses acne concerns and will be manufactured at the company's topical manufacturing facility in Changodar, Ahmedabad.

As reported by Zydus Lifesciences, Dapsone gel, with a 7.5 percent strength, recorded annual sales of USD 35.8 million in the US, based on IQVIA MAT March 2024 data.