NDMA pyrilamine protocols:

Executive Summary

In a May 31 letter to FDA, NDMA announces that it expects the results of two studies on the effectiveness of pyrilamine as a menstrual remedy ingredient to be available by early 1992, and requests an "early feedback meeting" to discuss "the specific details of the data analysis as outlined in the protocol, the manner of presentation of the data, additional analysis that might be undertaken and the general format of the submission." On behalf of Chattem and Sterling Drug's Glenbrook OTC division, NDMA has discussed protocol designs for pyrilamine studies in several past feedback meetings. The active ingredient is used in Chattem's Pamprin and Glenbrook's Midol. Pyrilamine was moved from Category I to Category III in the OTC Menstrual Products Tentative Final Monograph published in November 1988.