Jubilant Pharmova’s arm receives USFDA’s approval for Technetium Sulfur Colloid Injection

11 Nov 2023 Evaluate

Jubilant Pharmova’s wholly owned subsidiary -- Jubilant Draximage Inc has received approval from the United States Food and Drug Administration (USFDA) with regards to the company’s abbreviated new drug application (ANDA) submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C) for kit for the preparation of Technetium (Tc 99m) Sulfur Colloid Injection. For this approval, Jubilant is eligible for 180 days of exclusivity through the ‘Competitive Generic Therapy’ designation from the USFDA.

Technetium Sulfur Colloid Injection is used in the localization of metastatic lymph nodes in patients with breast cancer and melanoma, imaging of areas of the liver, spleen and bone marrow, and studies of esophageal transit, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. This approval is effective from November 9, 2023.

Jubilant Pharmova (formerly Jubilant Life Sciences) is a company engaged in pharmaceuticals, contract research and development services and proprietary novel drugs businesses.


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