Credit: Gorodenkoff Productions OU/stock.adobe.com Teva Launches CREATES Act Suit Against Galafold Drugmaker Over Access for Generic Development
This suit was surfaced by Law.com Radar. Read the complaint here.
July 13, 2021 at 04:19 PM
1 minute read
Pharmaceuticals
Teva Pharmaceuticals sued Philadelphia-based Amicus Therapeutics Tuesday in Pennsylvania Eastern District Court over the drugmaker's alleged refusal to provide access to product samples in accordance with the federal CREATES Act. The law, enacted in 2019, provides a timeline and mechanism for generic drugmakers to obtain samples of approved medications to support new generic drug applications. The suit, filed by Shook, Hardy & Bacon, accuses Amicus of withholding samples of its Galafold treatment for Fabry disease. Counsel have not yet appeared for the defendant. The case is 2:21-cv-03105, Teva Pharmaceuticals Development, Inc., v. Amicus Therapeutics U.S., Inc.
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