Novartis Wins Nicotine Gum Approval

The FDA's OK capped a solid week for the drugmaker.
Publish date:


(NVS) - Get Report

said Friday that the Food and Drug Administration approved its over-the-counter Thrive gum to help smokers kick the habit.

The company said the FDA approved Thrive 2mg for those who smoke fewer than 25 cigarettes a day and 4mg for those who smoke 25 or more cigarettes a day to help quit smoking in 12 weeks.

The nicotine replacement gum, which Novartis said helps smokers double their chances of quitting, delivers low, controlled levels of nicotine to the bloodstream to reduce cravings and withdrawal symptoms associated with quitting.

Novartis noted statistics from the Centers for Disease Control that indicate that smoking-related diseases claim the lives of an estimated 438,000 Americans each year and cost the U.S. more than $167 billion in health care. The company said that the Thrive approval follows a recent surgeon general's report that concluded smoke-free environments are the only approach that protects nonsmokers from the dangers of second-hand smoke.

This is the second FDA approval for the Basel, Switzerland-based company this week. Novartis announced Thursday it was cleared to sell

blood-pressure drug Exforge in the U.S.

In addition, the company said Friday that it received a positive opinion from the committee that reviews medicines for the European Union, recommending approval of blood-pressure treatment Rasilez. Novartis said it expects the commission to issue a decision in the next three months, and if Rasilez is approved it will be the first new type of high blood pressure treatment in more than a decade.

Novartis closed up 29 cents, or 0.5%, at $55.45 Friday.