Actavis confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Budesonide Extended-release Tablets, 9 mg.
DUBLIN, Feb. 24, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Budesonide Extended-release Tablets, 9 mg. Actavis' ANDA product is a generic version of Salix Pharmaceuticals' Uceris
, which is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Cosmo Technologies Limited and Santarus, Inc. filed suit against Actavis on February 17, 2015 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. Patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' 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.
Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Uceris
and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending December 31, 2014, Uceris
had total U.S. sales of approximately $123 million, according to IMS Health data.
Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.
Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.
For more information, visit Actavis' website at www.actavis.com.