Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (USFDA) for its abbreviated new drug application for Ascorbic Acid Injection USP, a generic version of Ascor Injection used primarily for the short-term treatment of scurvy. The approved product is available in strengths of 25,000 mg/50 mL (500 mg/mL) and 5,000 mg/10 mL (500 mg/mL). It will be manufactured at Zydus’s injectable facility in Jarod, near Vadodara, and marketed in the U.S. by Zydus Pharmaceuticals (USA) Inc.
The USFDA has designated this product as a Competitive Generic Therapy (CGT). Such products may qualify for 180-day exclusivity, depending on USFDA eligibility, starting from the first day of commercial marketing. This approval is expected to strengthen Zydus Lifesciences’ injectable drug portfolio and its presence in the U.S. pharmaceutical market.
