Zydus Lifesciences Shares Rise on USFDA Final Approval for Ammonium Lactate Cream

esciences Ltd. saw its share price gain in early trading on February 16, 2026, following the company's receipt of final approval from the United States Food and Drug Administration (USFDA) for its generic Ammonium Lactate Cream, 12%. The approval, announced on February 14, 2026, covers a topical prescription medication used to treat dry, scaly skin (xerosis) and the inherited condition ichthyosis vulgaris. The cream works by enhancing skin hydration and, as an alpha-hydroxy acid, helps relieve itching, soften the skin, and reduce scaling. At around 9:22 AM IST on February 16, Zydus Lifesciences shares were trading at Rs 912.20 on the BSE, up Rs 7.35 or 0.81%. The product, a generic version of Lac-Hydrin Cream, had estimated annual U.S. sales of approximately $15 million (based on IQVIA MAT December 2025 data). It will be manufactured at Zydus's topical facility in Changodar, Ahmedabad, and distributed in the U.S. by Viona Pharmaceuticals Inc. This latest nod strengthens Zydus's growing portfolio of USFDA-approved products, highlighting its focus on expanding in the dermatology and generics segment.