Jubilant Draximage bags USFDA nod for Technetium Mertiatide Injection
Noida: Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Draximage Inc has announced that it has received approval from the US Food and Drug Administration (USFDA) with regards to the Company's new drug application (NDA) submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Kit for the Preparation of Technetium (Tc 99m)...
Noida: Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Draximage Inc has announced that it has received approval from the US Food and Drug Administration (USFDA) with regards to the Company's new drug application (NDA) submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Kit for the Preparation of Technetium (Tc 99m) Mertiatide Injection.
The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older.
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The product enables providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex. This approval is effective from Jan 30, 2023.
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