Jubilant receives NDA approval for Drax Exametazime

From USFDA

Jubilant Life Sciences has announced that Jubilant Pharma, a material wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant Draximage Inc, Montreal, Canada, has received U.S. Food and Drug Administration (USFDA) approval for Drax Exametazime (Kit for the Preparation of Tc99m Exametazime for leukocyte labeling), for its New Drug Application (NDA) pursuant to section 505 (b) (2) filing. This approved new drug application is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease.

This is the sixth approval that the Company has received from the USFDA during the current financial year. As on 30 June 2017, Jubilant had a total of 84 ANDAs for Oral Solids filed in the US, of which 53 had been approved and 12 Injectable filings of which 9 had been approved.

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