Allendale Pharmaceuticals Today Sponge
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryProposed labeling for the nonoxynol-9 contraceptive sponge adequately explains that the sponge does not provide full protection from STDs and AIDS and sufficiently describes risks of toxic shock syndrome, FDA's Nonprescription Drugs Advisory Committee agrees July 12. The committee voted in favor of including comparative contraceptive efficacy information on the outer package of the OTC sponge. Allendale is attempting to re-market the sponge, which the company acquired from American Home Products in 1998. AHP had discontinued sale of the product due to quality control problem
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