Actavis confirmed that it has filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval to market Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release tablets. Actavis' ANDA product is a generic version of Duchesnay Inc.'s Diclegis, which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Duchesnay Inc. and Duchesnay USA Inc., filed suit against Actavis on July 10, 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. Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Diclegis.
- Company Legal & Law Matters