FDA approves Edgemont 60 mg depression drug NDA

Edgemont’s Fluoxetine 60 mg tablet is a single pill which is used to treat major depressive disorder, obsessive compulsive disorder in adults and pediatrics, and bulimia nervosa and panic disorder in adults.

The tablets also have a functional score to allow for a convenient half-tablet 30 mg dosing option.

Edgemont president and CEO Douglas Saltel said by reducing the number of pills per dose from three pills to one, they are hopeful that their Fluoxetine 60 mg tablets may help patients be more therapy compliant.

"This is an especially important goal for the higher milligram dose patients that may be having trouble controlling their symptoms of depression," Saltel said.