This article was originally published in The Tan Sheet
FDA's NDAC to discuss remarketing and labeling of the vaginal contraceptive July 12 at the Holiday Inn in Bethesda, Md. Allendale Pharmaceuticals, which acquired the brand from American Home Products in December 1998, submitted a supplemental NDA (18-683) for the nonoxynol-9 contraceptive. The product was discontinued by AHP in 1995 due to manufacturing quality control shortcomings. In an April 24 citizen petition, D.C.-based Associated Pharmacologists & Toxicologists asked FDA to ban OTC sale of the sponge (1"The Tan Sheet" May 8, p. 9). An inspection of Allendale's manufacturing facility slated for May 22 was postponed by the agency, the company says. The July 12 meeting will run from 1 p.m. to 5:30 p.m.; parties interested in speaking during the open portion must file written submissions by July 6
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The U.S. relaunch of the Today Sponge is on the horizon, with an FDA inspection of the manufacturing facility for the OTC nonoxynol-9 contraceptive slated for the week of May 22. The product's marketer, Allendale Pharmaceuticals, submitted a supplemental NDA Jan. 23.
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