New Delhi: Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic version of ascorbic acid injection used for short-term treatment of scurvy.
The final approval by the US Food and Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for ascorbic acid injection of strengths 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL), Zydus Lifesciences Ltd said in a regulatory filing.
The product is primarily used for short-term treatment of scurvy in adult and paediatric patients aged 5 months and older for whom oral administration is not possible, insufficient or contraindicated, it added.
Zydus said its product 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 first day of commercial marketing of the product," the company noted.
As per the USFDA, the regulator may designate a drug as a CGT after determining that there is inadequate generic competition for that drug and there is not more than one approved drug included in its active approved list.
The company said the product will be manufactured at the group's USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat and it will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc.
The branded product had annual sales of approximately USD 11.6 million in the US, Zydus said citing IQVIA MAT June 2026 data.
