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Wednesday, Watson Pharmaceuticals Incorporated announced that United States health regulators had approved the company’s version of GlaxoSmithKline Plc’s Nicorette mint gum, which is an over-the-counter product aimed at helping smokers kick the habit.
Moreover, Watson said that it planned to render the generically known as Nicotine Polacrilex gum product available in early January, adding that the approval obtained concerned the 2 milligram and 4 milligram strengths.
According to the company, annual sales for OTC nicotine gum amounted to over $300 million during the fiscal year that ended this September.
Watson also informed that it had issued applications to the United States Food and Drug Administration (FDA) so as to be granted the request to market more flavors of nicotine gum, in an attempt to expand its line of products for quitting smoking.
Currently, Nicorette is made by British drug maker GlaxoSmithKline and marketed by Johnson & Johnson Healthcare, while the product, presently available in six flavors, was approved by the FDA in February 1996.
In other news, Watson Laboratories Incorporated, a unit of Watson Pharmaceuticals Inc, stated that the FDA had given them the final approval for their Abbreviated New Drug Application (ANDA) for desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg, a low-dose monthly oral contraceptive product.
The product is scheduled to be launched in January under the Azurette trade name, being the generic equivalent to Duramed Pharmaceuticals’ Mircette pills. The latter has registered sales of $135 million throughout the U.S within the previous fiscal year.
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