Circa Pharmaceuticals
Receives FDA approval for its 4 mg polacrilex nicotine gum (ANDA 74-707) March 19. The Watson Pharmaceutical subsidiary also receives approval for a 2 mg version of the product (ANDA 74-507) March 15. SmithKline Beecham's Nicorette smoking cessation gum, the reference product, lost its Waxman/Hatch exclusivity Feb. 9, but launched a mint-flavored gum in January to stave off the private label competition ("The Tan Sheet" Jan. 18, p. 4). The Circa product is the first private label nicotine gum to be approved by the agency. Novopharm, Gumtech and Perrigo also are expected to market nicotine replacement gum in the future