Jubilant Life Sciences, an integrated global Pharmaceutical and Life Sciences Company, 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 we have received from the USFDA during the current financial year. As on June 30, 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.
Shares of the company gained Rs 0.45, or 0.06%, to trade at Rs 704.80. The total volume of shares traded was 28,975 at the BSE (2.57 p.m., Monday).