FDA takes aim at Abilify marketing material
A pharmacology aid for the depression drug Abilify (aripiprazole) ran afoul of the FDA's Office of Prescription Drug Promotion, the division that oversees prescription drug advertisements.
The April 17 letter to the drug's manufacturer, Otsuka, focuses on a visual aid that shows three dimmer switches with the switch at low, high and middle heights to represent chemical states. The mid-height slider is meant to represent Abilify's ability to modulate mood. The drug is indicated for bipolar disorder and major depressive disorder.
OPDP wrote that the visual representation and the accompanying text implies attributes of the drug that the label cannot support. The letter said how the drug works is unknown and the efficacy of aripiprazole could be affected by other factors.
The letter also said that the promotional material implies that Abilify has advantages over similarly indicated medications. The FDA wrote that this, too, cannot be supported.
The letter was released the same week that the regulator announced it had approved the first generic versions of the drug. The branded drug has managed to maintain market share despite competition from generics for the same conditions.