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Back To News: Additional Duloxetine DR Strength
Additional Duloxetine DR Strength
[May 21, 2018]

Breckenridge Announces Approval for 40mg Duloxetine Delayed-release Capsules additional strength.


Boca Raton, Florida, May 18, 2018– 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.



For Further Information, please contact:


Breckenridge Pharmaceutical, Inc.


Brian Guy, Senior Vice President – Business Operations


TEL:     860-828-8140     




*Cymbalta® is a registered trademark of Eli Lilly and Company


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