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BOCA RATON, Fla., June 12, 2014 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Duloxetine Delayed-release Capsules. The U.S. 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 (MDD) Major Depressive Disorder. This milestone signifies the first vertically-integrated product developed and commercialized between Breckenridge and Esteve.
(The API is sourced from Esteve Quimica, Esteve's API division.)
Breckenridge is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products and Medical Foods in many therapeutic categories. The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide. The company markets over 60 products in a variety of dosage forms including: Tablets, Capsules, Soft Gel Capsules, and Liquids, and Powders.
*Cymbalta® is a registered trademark of Eli Lilly and Company