Zydus Lifesciences Gets USFDA Nod for Ascorbic Acid Injection

Zydus Lifesciences Limited has received final approval from the USFDA for its Ascorbic Acid Injection USP. This approval includes 180-days of Competitive Generic Therapy (CGT) exclusivity. The injection is used for the short-term treatment of scurvy when oral administration is not feasible. The product is the generic equivalent of Ascor® Injection and will be manufactured at Zydus' USFDA-approved facility in Gujarat. The brand product had annual sales of approximately USD 11.6 million in the US. Zydus now has 448 approvals and has filed 513 ANDAs with the USFDA.