FDA approves dosage for antidepressant

Edgemont's 60 mg fluoxetine tablets approved

AUSTIN, Texas — The Food and Drug Administration has approved a new strength for a psychiatric drug made by Edgemont Pharmaceuticals, Edgemont said Tuesday.

The drug maker announced the approval of a 60 mg dose of fluoxetine tablets, a treatment for major depressive disorder, obsessive compulsive disorder, bulimia nervosa and panic disorder. The drug was originally marketed under the brand name Prozac.

"By reducing the number of pills per dose from three pills to one, we are hopeful that our fluoxetine 60 mg tablets may help patients be more therapy-compliant," Edgemont president and CEO Douglas Saltel said. "This is an especially important goal for the higher-milligram dose patients that may be having trouble controlling their symptoms of depression."


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