FDA grants priority review to Pfizer smoking cessation drugPfizer said today that the FDA has granted a six-month priority review for the New Drug Application (NDA) for its smoking cessation drug, varenicline tartrate, which the company intends to market under the brand name Champix.
Under priority review, the FDA will make a decision on whether or not to approve the drug within six months, rather that the usual 10-12 month review period.
Hank McKinnell, chairman and CEO of Pfizer said in a statement, "Pfizer's research and development effort for Champix represents the best of what medical innovation can bring to patients and families struggling to overcome tobacco addiction."
In all trials, Pfizer said, varenicline was well tolerated, with "overall discontinuation rates similar to placebo."
Pfizer submitted the NDA for varenicline tartrate in November 2005.