Zydus gets U.S. FDA nod for Ammonium lactate cream

Generic drugmaker Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration for Ammonium Lactate Cream, 12%.

The product will be manufactured at the group’s topical manufacturing site in Ahmedabad and distributed by Viona Pharmaceuticals Inc. Ammonium lactate cream had annual sales of $15 million in the U.S., Zydus said citing IQVIA MAT December 2025 numbers.

A topical prescription medication, Ammonium lactate cream, 12% is indicated for the treatment of dry, scaly skin (xerosis) and an inherited dry skin condition called ichthyosis vulgaris. It is used to moisturise the skin by increasing hydration and as an alpha-hydroxy acid, helps relieve itching, soften skin, and decrease skin scaling, the company said.