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Clinical Trials
0
0 active
Approvals
627
Total approvals
Agencies
1
Regulatory bodies
Founded
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No trial phase data available
No trial data available
FDA
Food and Drug Administration
- Zydus Lifesciences received final USFDA approval for its Ascorbic Acid Injection USP in strengths of 25,000 mg/50 mL and 5,000 mg/10 mL (500 mg/mL). - The injection is indicated for short-term treatment of scurvy in adult and pediatric patients aged 5 months and older when oral administration is not feasible. - The USFDA granted 180 days of Competitive Generic Therapy (CGT) exclusivity, commencing from the first day of commercial marketing. - The product, a generic equivalent of McGuff Pharmaceuticals' Ascor (annual US sales of about $11.6 million), will be manufactured at Zydus' Jarod facility in Gujarat.
