This article was originally published in The Tan Sheet
Allendale Pharmaceuticals expects to bring the female contraceptive to market in the first quarter of 2000. The firm plans to submit its supplemental NDA to FDA in mid-November. Allendale noted it already has reached an agreement with a major drug chain and expects to ship the sponge, which will come in 3- and 6-count sizes, to food, drug and mass outlets. A Web site, todaysponge.com, is under construction. The company first announced its intent to reintroduce the nonoxynol-9 contraceptive in March (1"The Tan Sheet" March 15, p. 14). American Home Products discontinued manufacturing the product in 1995 for economic reasons
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The Today Contraceptive Sponge is slated to be reintroduced by early to mid-autumn. The OTC nonoxynol-9 sponge product was discontinued in 1995 by then-owner American Home Products due to quality control shortcomings and a decision by the firm not to devote more resources to upgrading its manufacturing facility to meet FDA standards. The agency issued a statement at the time affirming the sponge's safety.
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Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC