Executive Summary

FDA denies request by Pharmacontrol to include sodium aspirin in the internal analgesics monograph as a subset of aspirin or as a separate ingredient. In a June 4 letter, FDA stated that "aspirin and sodium aspirin are chemically related but are not identical," and asked the firm to submit information on the marketing history of sodium aspirin in other countries and on sodium aspirin's inclusion in any pharmacopeia. Pharmacontrol has been developing soluble sodium aspirin for nearly a decade.