Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL).
The product, primarily used for the short-term treatment of scurvy, is a generic of reference listed drug Ascor Injection. The USFDA has designated the ANDA as a competitive generic therapy. Eligibility for the 180-day exclusivity available to certain CGT is determined by the U.S. FDA and where applicable the period runs from the date of first day of commercial marketing of the product, Zydus said.
The product will be manufactured at the group’s injectable manufacturing plant in Jarod, near Vadodara and marketed in the US by Zydus Pharmaceuticals (USA) Inc. The brand product had annual sales of $11.6 mn in the U.S., Zydus said, citing IQVIA MAT June-2026 numbers.
Published – August 21, 2026 09:13 pm IST
