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OTC EXPECTORANT, NIGHTTIME SLEEP-AID FINAL MONOGRAPHS DUE OUT

Executive Summary

OTC EXPECTORANT, NIGHTTIME SLEEP-AID FINAL MONOGRAPHS DUE OUT before the end of 1988, FDA OTC Drug Evaluation Division Director William Gilbertson, PharmD, told the Food & Drug Law Institute's 32nd Annual Education Conference Nov. 30. Gilbertson's prediction for publication of the expectorant monograph is somewhat earlier than FDA's most recent regulatory agenda, which slated release of the final rule for April 1989. The regulatory agenda, published in the Oct. 24 Federal Register, set an October 1988 date for the nighttime sleep-aid final rule. Among the monograph rulings planned for 1989, tentative final monographs for weight control aids, vaginal products and sunscreens are anticipated, Gilbertson said. The FDAer also predicted that the TFM for topical antifungals, an amendment to the first aid antiseptic TFM, and final action on aphrodisiacs will be published "soon." According to FDA's "regulatory agenda, the antifungal TFM is slated to come out in December, the TFM for antiseptics in February and the final rule on aphrodisiacs in April of next year. Reviewing recent agency actions, Gilbertson noted that the sunscreen supplier Givaudan is asking that the monograph be amended to include the sodium salt form of 21-phenylbenzimidazole-5-sulfonic acid. At present, only the acid form of that chemical is in the monograph. In an Oct. 28 letter to the Hoffmann-LaRoche subsidiary, FDA requested additional data "to confirm the similarity in chemical activity of the sodium salt to the free acid form, adequate evidence that the sodium salt is effective" and data on whether or not that form of the ingredient was contained in marketed products before Dec. 4, 1975, Gilbertson said. Ingredients not present in products on the market prior to that date or not evaluated during the OTC review process cannot be used without either an approved new drug application, inclusion in a monograph or becoming generally recognized as safe by FDA.
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