Breckenridge announced the supplemental approval for the 40mg strength of Duloxetine Delayed-Release Capsules.
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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 are underway.