Lupin Pharmaceuticals Launches Duloxetine as a Generic Antidepressant
September 3, 2015 – Lupin Pharmaceuticals launched the first duloxetine 40mg delayed-relesase capsules, a generic antidepressant in the serotonin-norephinephrine reuptake inhibitor (SNRI) class. The U.S. Food and Drug Administration (FDA) approved duloxetine for the treatment of major depressive disorder, generalized anxiety disorder, peripheral neuropathic pain from diabetes and chronic musculoskeletal pain. Included in duloxetine’s label, is a boxed warning that using it may increase the risk of suicide or suicidal thoughts if taken by patients younger than 24 years or age. Duloxetine delayed-release capsules come in other strengths (20mg, 30mg, and 60mg) that have been on the market since December 2013. The innovator brand Cymbalta, manufactured by Lilly, does not have 40mg strength available.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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