India, Aug. 21 -- Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for its generic Ascorbic Acid Injection USP in two strengths, used for the short-term treatment of scurvy in patients aged five months and above who cannot take the medicine orally.
The USFDA has designated the product as a Competitive Generic Therapy (CGT), making it eligible for 180-day exclusivity, subject to regulatory conditions.
The injection will be manufactured at Zydus' USFDA-approved facility in Jarod, Gujarat, and marketed in the US by Zydus Pharmaceuticals (USA). The reference product recorded annual US sales of approximately USD 11.6 million as of June 2026, according to IQVIA data.
With this approval, Zydus' gro...