FDA Grants Approval to Market Generic Fluoxetine Tablets

FEBRUARY 12, 2019
Gina Kokosky, Assistant Editor
FDA officials have recently approved Lupin Pharmaceuticals' generic version of fluoxetine tablets, USP, 60mg. The tablets are comparable to Alvogen’s Fluoxetine Tablets, 60mg.1

Flouxetine tablets were approved with the indication of treating multiple mental conditions, including major depressive disorder, obsessive compulsive disorder, bulimia nervosa, and panic disorder with or without agoraphobia.1

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI), a drug that treats mental illnesses by increasing the production of serotonin in the brain.

Due to adverse effects and drug interactions, patients should weigh the benefits and risks of beginning fluoxetine with their physicians. Patients may not notice a significant change until a month after beginning therapy with fluoxetine.2

  1. Lupin Receives FDA approval for Fluoxetine Tablets USP [news release]. Mumbai, India and Baltimore, Maryland; February 12, 2019: Lupin Pharmaceuticals News Room. http://www.lupinpharmaceuticals.com/lupin-receives-fda-approval-for-fluoxetine-tablets-usp.htm. Accessed Feb 14, 2019.
  2. Drugs and Supplements: Fluoxetine (Oral Route). Mayo Clinic website. https://www.mayoclinic.org/drugs-supplements/fluoxetine-oral-route/proper-use/drg-20063952. Updated February 1, 2019. Accessed February 14, 2019.