Lake's Advantage 24 contraceptive is outside OTC review -- FDA warning letter.
This article was originally published in The Tan Sheet
Executive Summary
"24-HOUR" CLAIM PUTS ADVANTAGE 24 CONTRACEPTIVE OUTSIDE OTC REVIEW, FDA told Lake Pharmaceuticals in a warning letter dated Sept. 5, 1995 but only recently released by the agency. The claim for the nonoxynol-9-containing product that its "patented bioadhesive gel...ensures that the spermicide remains in place...for up to 24 hours" distinguishes Advantage 24 from shorter-duration N-9 products currently included in the OTC vaginal contraceptives monograph, according to the agency.