Zydus Gets USFDA Final Nod for Ascorbic Acid Injection, Gains Competitive Generic Therapy Status
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL) and 5,000 mg/10 mL (500 mg/mL).
The product is primarily indicated for the short-term treatment of scurvy in adult and pediatric patients aged 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
Zydus’ Ascorbic Acid Injection is the generic equivalent of the reference listed drug (RLD), Ascor® Injection, 25,000 mg/50 mL (500 mg/mL).
The USFDA has designated the ANDA for the product as a Competitive Generic Therapy (CGT). Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period runs from the date of the first commercial marketing of the product.
The product will be manufactured at Zydus' USFDA-approved injectable manufacturing facility at Jarod, near Vadodara, Gujarat, and will be marketed in the US by Zydus Pharmaceuticals (USA) Inc.
According to the company, the reference brand product recorded annual sales of approximately $11.6 million in the United States, based on IQVIA MAT data for June 2026.
With this approval, the Zydus Group now has 448 approvals and has filed 513 ANDAs with the USFDA as of June 30, 2026.
