Federal Register #FDA-2025-E-0162

FDA Notice: Regulatory Review Period Determination for VYALEV Drug Patent Extension

This notice from the Food and Drug Administration (FDA) provides information on the regulatory review period determination for the VYALEV drug product: - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEMs and Vendors: - AbbVie Inc. (patent holder and manufacturer of VYALEV) - Products/Services Requested: - No procurement of products or services is requested in this notice - The notice pertains to the regulatory review period for the VYALEV drug, used for treating motor fluctuations in adults with advanced Parkinson's disease - Unique or Notable Requirements: - The notice is related to patent extension applications submitted to the U.S. Patent and Trademark Office (USPTO) - The total regulatory review period for VYALEV is 2,871 days, including both testing and approval phases - The FDA is inviting public comments and petitions regarding the accuracy of the review period dates and the applicant's due diligence - No solicitation for goods or services is included; this is an informational regulatory announcement

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human drug product VYALEV, which is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. This determination is published as required by law following the submission of applications to the U.S. Patent and Trademark Office for patent extension. The regulatory review period consists of a testing phase and an approval phase, totaling 2,871 days. The FDA invites comments and petitions regarding the dates and due diligence of the applicant during the regulatory review period.

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