Zydus Lifesciences announced it has received final approval from the USFDA for its Ascorbic Acid Injection USP. This approval includes 180-days of Competitive Generic Therapy (CGT) exclusivity, marking a significant step for the company’s US market presence. The product, used for scurvy treatment, will be manufactured at Zydus’ USFDA-approved plant and marketed by its US subsidiary.
USFDA Approval for Ascorbic Acid Injection
Zydus Lifesciences Limited has announced the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP. The approved strengths are 25,000 mg/50 mL (500 mg/mL) and 5,000 mg/10 mL (500 mg/mL).
Therapeutic Use and Exclusivity
This injection is primarily indicated for the short-term treatment of scurvy in adult and pediatric patients aged 5 months and older, particularly when oral administration is not feasible, insufficient, or contraindicated. Notably, the USFDA has designated this ANDA as a Competitive Generic Therapy (CGT), granting Zydus eligibility for 180-days of CGT exclusivity. This exclusivity period commences from the first day of commercial marketing.
Manufacturing and Marketing
The Ascorbic Acid Injection will be manufactured at Zydus’ USFDA-approved injectable manufacturing facility located in Jarod, near Vadodara, Gujarat. The product will be marketed in the United States by Zydus Pharmaceuticals (USA) Inc. The brand product (RLD), Ascor® Injection, had annual sales of approximately USD 11.6 million in the United States as of June 2026.
Company Milestones
With this latest approval, Zydus Lifesciences now holds 448 approvals and has filed a total of 513* ANDAs with the USFDA as of June 30, 2026.
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