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news.Irish specialty pharmaceutical firm Actavis has submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market Budesonide Extended-release Tablets, 9mg.
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The company’s ANDA product is a generic version of Salix Pharmaceuticals’ Uceris, which is a glucocorticosteroid designed for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC), a form of inflammatory bowel disease (IBD).
Earlier this month, Cosmo Technologies and Santarus had filed a lawsuit, under the provisions of the Hatch-Waxman Act, against Actavis in the US District Court for the District of Delaware seeking to prevent the Irish firm from commercializing its ANDA product before the expiration of certain US patents.
The lawsuit resulted in a stay of final FDA approval of the ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Actavis develops and manufactures generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products and has commercial operations in about 60 countries.