Now Reading: Zydus gets US FDA approval for scurvy injection generic
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Zydus gets US FDA approval for scurvy injection generic
Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Ascorbic Acid Injection USP, used for short-term treatment of scurvy. The product…
Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Ascorbic Acid Injection USP, used for short-term treatment of scurvy. The product is a generic version of the reference listed drug Ascor Injection.
The FDA has designated the application as a competitive generic therapy, which may qualify Zydus for 180-day exclusivity from the first day of commercial marketing in the U.S. The injection will be manufactured at Zydus's plant in Jarod near Vadodara and marketed by Zydus Pharmaceuticals (USA) Inc.
The brand product had annual sales of $11.6 million in the U.S., according to IQVIA MAT June 2026 data cited by Zydus.
Indian Opinion Analysis
This approval opens a niche but stable revenue stream for Zydus in the U.S. injectable market, where it already has a presence. Scurvy, though rare in developed countries, occurs in vulnerable populations such as the elderly, alcoholics, and those with malabsorption disorders, ensuring steady demand. The competitive generic therapy designation could give Zydus a 180-day head start over other generic entrants, potentially capturing most of the $11.6 million market. The real value lies in the exclusivity window, after which prices typically drop sharply. Investors should watch the commercial launch date to gauge when the exclusivity clock starts.
Source: thehindu.com
This story was synthesised by AI from the source linked above.
