Federal Register #2026-18300

FDA Regulatory Review Period Determination for ANDEMBRY (garadacimab-gxii) Patent Extension

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces the determination of the regulatory review period for the human biological product ANDEMBRY (garadacimab-gxii). - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - CSL Behring GmbH - CSL Ltd. - Product Details: - ANDEMBRY (garadacimab-gxii), a biological product - Indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients aged 12 years and older - Purpose of Notice: - Related to a patent extension application submitted to the U.S. Patent and Trademark Office (USPTO) - FDA verified the regulatory review period, including testing and approval phases - Unique/Notable Requirements: - Public comments and petitions are invited regarding the determination and the applicant's due diligence during the review period - No procurement or contract award is involved; this is a regulatory and informational notice only

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human biological product ANDEMBRY (garadacimab-gxii), which is indicated for prophylaxis to prevent attacks of hereditary angioedema in patients aged 12 years and older. This determination is made following the submission of an application to the U.S. Patent and Trademark Office (USPTO) for patent extension. The regulatory review period consists of a testing phase and an approval phase, with specific dates verified by the FDA. The notice invites comments and petitions regarding the determination and due diligence of the applicant during the regulatory review period.

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