Teva, In First-Ever CREATES Act Suit, Seeks Help With Fabry Disease Generic Development

Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.

Tip of the spear — In what could be the tip of the spear, Teva is attempting to become the first company to gain a court order to compel the sale of a brand drug for generic development. • Source: Alamy

Teva Pharmaceutical Industries Ltd. has sued Amicus Therapeutics, Inc. to force the sale of samples of a rare disease drug in what is believed to be the first court test of the CREATES Act.

Teva filed the complaint on 13 July, alleging that Amicus refused to sell the company sufficient quantities of its...