FDA grants priority review to Pfizer smoking cessation drug

Share this article:
Pfizer 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.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.