Federal Register #FDA-2024-E-4125

FDA Regulatory Notice for Patent Extension of ANKTIVA (Nogapendekin Alfa Inbakicept-pmln)

This notice from the Food and Drug Administration (FDA) addresses the regulatory review period for the patent extension of ANKTIVA, a human biological product. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEM/Vendor: - Altor BioScience, LLC (applicant for patent extension) - Product Details: - ANKTIVA (nogapendekin alfa inbakicept-pmln) - Indicated for use with Bacillus Calmette-Guerin (BCG) in adult patients with BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ - Patent numbers involved: 8,507,222; 9,255,141; 9,328,159; 10,150,805; 11,173,191 - Unique Requirements: - Determination of regulatory review period for patent extension - Public comments and petitions invited regarding the determination and review process - No products or services are being procured or awarded; this is a regulatory notice related to patent extension.

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human biological product ANKTIVA. This determination is made following the submission of an application to the U.S. Patent and Trademark Office for the extension of patents claiming this product. The regulatory review period includes a testing phase and an approval phase, with specific dates verified by the FDA. The FDA invites comments and petitions regarding the dates and the review process, with deadlines specified for submissions.

View original listing