Zydus Lifesciences Receives USFDA Approval for Ascorbic Acid Injection with 180-Day CGT Exclusivity
核心洞察
Zydus Lifesciences received final USFDA approval for its Ascorbic Acid Injection USP (搜索) in strengths of 25,000 mg/50 mL and 5,000 mg/10 mL (500 mg/mL).
The injection is indicated for short-term treatment of scurvy (搜索) in adult and pediatric patients aged 5 months and older when oral administration is not feasible.
The USFDA granted 180 days of Competitive Generic Therapy (CGT) exclusivity, commencing from the first day of commercial marketing.
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 (搜索), the company announced. The approval covers two strengths — 25,000 mg/50 mL (500 mg/mL) and 5,000 mg/10 mL (500 mg/mL) — and carries a 180-day Competitive Generic Therapy (CGT) exclusivity designation, a milestone that strengthens the company's presence in the US market.
The injection is indicated for the short-term treatment of scurvy (搜索) in adult and pediatric patients aged 5 months and older, particularly in cases where oral administration is not feasible, insufficient, or contraindicated. The USFDA has designated this ANDA as a Competitive Generic Therapy, granting Zydus eligibility for 180 days of CGT exclusivity, a period that commences from the first day of commercial marketing.
The product will be manufactured at Zydus' USFDA-approved injectable manufacturing facility located in Jarod, near Vadodara, Gujarat, and will be marketed in the United States by Zydus Pharmaceuticals (USA) Inc. The therapy is the generic equivalent of McGuff Pharmaceuticals' Ascor Injection, which recorded annual sales of approximately USD 11.6 million in the United States as of June 2026, according to IQVIA.
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. The approval underscores the company's continued expansion of its injectable portfolio and its growing footprint in the competitive US generics market.