USFDA Approval: In the fast-paced world of pharmaceuticals, Jubilant Pharmova Limited, through its subsidiary Jubilant Draximage Inc, has recently achieved a significant milestone.
The US Food and Drug Administration (USFDA) has given its nod to the company’s abbreviated new drug application (ANDA) for the preparation of Technetium (Tc 99m) Sulfur Colloid Injection, a crucial development in the field of nuclear medicine.
This article delves into the details of this groundbreaking announcement, exploring the implications of USFDA approval and shedding light on the various aspects of Jubilant Pharmova Limited’s operations.
II. USFDA Approval and Exclusivity
The USFDA’s approval, granted under section 505(j) of the Federal Food, Drug, and Cosmetic Act, comes with the added benefit of 180 days of exclusivity.
This exclusivity, attributed to the ‘Competitive Generic Therapy’ designation, holds strategic importance in the competitive pharmaceutical landscape.
III. Technetium Sulfur Colloid Injection
Technetium Sulfur Colloid Injection plays a vital role in medical diagnostics.
Its applications range from localizing metastatic lymph nodes in breast cancer and melanoma patients to imaging areas of the liver, spleen, and bone marrow.
Additionally, it is instrumental in studies related to esophageal transit, gastroesophageal reflux, and the detection of pulmonary aspiration of gastric contents.
IV. Effective Date and Duration
The approval, effective from Nov 9, 2023, marks the beginning of a 180-day window where Jubilant Pharmova Limited can exclusively market this drug.
This period offers a competitive edge, allowing the company to establish its presence in the market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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