Breckenridge Announces Approval for 40mg Duloxetine Delayed-release Capsules additional strength.
Breckenridge Announces Approval for 40mg Duloxetine Delayed-release Capsules additional strength.
BOCA RATON, Fla., May 21, 2018 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today the supplemental approval for the 40mg strength of Duloxetine Delayed-Release Capsules. The U.S. Food and Drug Administration granted final approval for the Supplemental Abbreviated New Drug Application (sANDA), which is being manufactured and supplied by its vertically integrated parent company, Esteve Pharmaceuticals, S.A. Duloxetine Delayed-release Capsules are AB rated to Cymbalta®, a drug marketed by Eli Lilly, for the treatment of Major Depressive Disorder, Generalized Anxiety Disorder, Diabetic Peripheral Neuropathy and Chronic Musculoskeletal Disorder. According to industry data, the prior 12 month's sales for the 40mg strength were estimated at $25M. Launch plans for this product are underway.
About Breckenridge:
Breckenridge Pharmaceutical, Inc. is a privately-held own-label distributor that performs pharmaceutical marketing, research and development, as well as marketing and distribution in the U.S. The company was founded in 1983 and markets a broad range of generic prescription products 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 70 products in a variety of dosage forms including: tablets, capsules, soft gel capsules, liquids, suspensions, ophthalmics, nasal sprays, powders and injectable products. www.bpirx.com
*Cymbalta® is a registered trademark of Eli Lilly and Company
CONTACT: For Further Information, please contact: Breckenridge Pharmaceutical, Inc., Brian Guy, Senior Vice President - Business Operations, TEL: 860-828-8140, e-Mail: bguy@bpirx.com
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SOURCE Breckenridge Pharmaceutical, Inc.
