Watson Wins FDA Approval For Mint-Flavored Nicorette

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Watson Pharmaceuticals, Inc. said on Wednesday that its subsidiary Watson Laboratories, Inc. has received the approval from U.S. health regulators to sell an over-the-counter product designed to help smokers quit.

The over-the-counter Nicotine Polacrilex Gum, coated mint flavor is the generic equivalent of Nicorette fresh mint gum, another medicine used to cease smoking. Nicorette is manufactured by British drug maker GlaxoSmithKline PLC in Helsingborg, Sweden, and sold by Johnson & Johnson Healthcare.

Nicotine Polacrilex Gum, which has received the Food and Drug Administration approval in the 2 mg and 4 mg strengths, is expected to be purchased since the first quarter of 2009.

California-based Watson said the annual sales of the product reach more than $300 million.

"The approval of our mint flavored, coated nicotine gum is a significant addition to our line of generic smoking cessation products," said Paul Bisaro, Watson's President and Chief Executive Officer, adding that the company also has applications pending at the FDA to market additional flavors of nicotine gum.

Tobacco use is the primary preventable cause of disease, disability, and death in the U.S. The chemicals tobacco contains claim the lives of more than 400,000 Americans each year, the Centers for Disease Control and Prevention found.


Cigarette smoke is known to contain more than 4,000 chemicals, including 43 known carcinogenic compounds and over 400 other toxins. These include nicotine, carbon monoxide, formaldehyde, hydrogen cyanide, as well as arsenic and DDT, a synthetic pesticide.

Taken in small doses, nicotine acts as a stimulant to the brain. In large doses, it acts like a depressant, reducing the stream of signals between nerve cells. In larger doses, nicotine is poisonous as it affects vital organs. When a tobacco product is chewed, inhaled or smoked, nicotine is quickly absorbed into the bloodstream.