Zydus secures U.S. FDA nod for scurvy injection generic
Zydus Lifesciences has received U.S. FDA approval for a generic version of an ascorbic acid injection used to treat scurvy. The company plans to manufacture the drug in India and market it in the United States.
Why it matters
FDA approval for generic drugs increases market competition and can lower healthcare costs for patients requiring specific treatments.
Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL).
The product, primarily used for the short-term treatment of scurvy, is a generic of reference listed drug Ascor Injection. The USFDA has designated the ANDA as a competitive generic therapy. Eligibility for the 180-day exclusivity available to certain CGT is determined by the U.S. FDA and where applicable the period runs from the date of first day of commercial marketing of the product, Zydus said.
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