Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Draximage Inc (‘Company’) today announced that it has received approval from the US FDA 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, the company announced through an exchange filing.
For this approval, Jubilant is eligible for 180 days of exclusivity through the ‘Competitive Generic Therapy’ designation from the US FDA.
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.
Pramod Yadav, CEO, Jubilant Radiopharma business said, “At Jubilant, we are glad to announce approval for Sulfur Colloid, which will improve availability of this critical radiopharmaceutical to patients and healthcare professionals. Technetium Sulfur Collid is our second product to be launched in FY24 after the approval and launch of Technetium Mertiatide Injection in Q1’FY24 and highlights our strong focus on the nuclear medicine business and commitment towards improving patient lives.”