Tag: Generic drugs
Skinny Labeling: Impact of GSK v. Teva on Regulatory Compliance and Generics Market
Congress enacted the Hatch-Waxman Act to strike a balance between promoting generic competition and encouraging pharmaceutical innovation. The Act requires innovators to disclose patents to the FDA for listing in the Orange Book, while...
Amneal Removes Teva Patents from Orange Book with FTC HelpAmneal FTC Success: Teva Patents...
In a recent court ruling, the United States District Court for the District of New Jersey has determined that Teva's inhaler patents were incorrectly listed in the FDA's Orange Book. This decision supports Amneal's...