FDA Tells Citius That Suprenza Web Page Is False, Misleading in ‘Untitled’ Letter

The Food and Drug Administration has told Citius Pharmaceuticals LLC that a Web page for Suprenza (phentermine hydrochloride orally disintegrating tablets) is false or misleading because it omits risk information and material facts and includes unsubstantiated efficacy claims, according to an “untitled” letter posted recently on the FDA’s website.

Suprenza is indicated as a short-term adjunct in a regimen of exercise, behavioral modification and caloric restriction to manage exogenous obesity for patients with a certain body mass index. The drug was approved in 2011 9 PLIR 796, 6/24/11.

The drug is contraindicated:

• in patients with a history of cardiovascular ...