OTC use of promethazine
In a Nov. 27 letter to FDA, Wyeth-Ayerst requested that, if FDA decides to ask the advice of another advisory committee on the safety and efficacy of promethazine for OTC use, it be a special ad hoc panel consisting of members with expertise in SIDS/sleep apnea, pediatric neurology and epidemiology, and a knowledge of the regulatory basis for Rx to OTC switches. In July 1989, an Rx advisory committee overturned FDA's recommended switch for the drug.
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