Pipeline Report: Recent FDA Approvals

FDA Approves varenicline tartrate for aid in smoking cessation

Varenicline tartrate pill (Chantix, Pfizer) approved as smoking cessation aid.

Recommended starting dose of varenicline tartrate is 0.5 mg QD for the first three days. Patients should take 0.5 mg BID on days 4 through 7, following which patients should take 1 mg BID for the duration of treatment.

The approval was based on the results of a comprehensive clinical trial program including over 3,500 cigarette smokers. Five randomized, controlled clinical trials showed varenicline tartrate to be superior to placebo in helping people to quit smoking.

Full prescribing information can be found at www.chantix.com.