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NDMA reanalysis of pyrilamine data for menstrual cramp claim urged by FDA.

This article was originally published in The Tan Sheet

Executive Summary

NDMA REANALYSIS OF PYRILAMINE DATA MAY SUPPORT MENSTRUAL CRAMP CLAIM, FDA told the Nonprescription Drug Manufacturers Association in a Jan. 3 letter. Referring to two studies submitted by NDMA to support the use of pyrilamine maleate for the relief of premenstrual/menstrual pain and cramps ("The Tan Sheet" May 2, 1994, p. 8), the agency said the data "do not support an indication" for the relief of both premenstrual pain and cramps. However, the agency added, "if the studies are reanalyzed,...they may support a claim for relief of menstrual cramps."

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