Breckenridge Pharmaceutical, Inc., a privately-held pharmaceutical marketing, research and development company, launches duloxetine delayed-release capsules.
The US Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by its parent company, Laboratorios Dr. Esteve, S.A. Barcelona, Spain, and will be available in 20mg, 30mg and 60mg strengths.
Duloxetine delayed-release capsules are AB rated to Cymbalta, a drug marketed by Eli Lilly, for the treatment of major depressive disorder (MDD). This milestone signifies the first vertically-integrated product developed and commercialised between Breckenridge and Esteve.