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Executive Summary

PHARMACONTROL SODIUM ACETYLSALICYLATE CLASSIFICATION AS "SUBSET OF ASPIRIN" should be established by FDA, qualifying the drug for Category I OTC status, the company said in a recent letter to the agency. In the letter, PharmaControl's outside attorney Robert Pinco (D.C. law firm Perito, Duerk and Pinco) requested an advisory opinion from the agency that "sodium acetylsalicylate is generally recognized as safe and effective for OTC use as a subset of aspirin when labeled as an analgesic active ingredient for oral administration." Alternatively, the company asserted, "if aspirin and its sodium salt are to be differentiated by the agency, the opinion should verify the implicit and/or explicit recommendations of two expert advisory panels that sodium acetylsalicylate is itself generally recognized as safe and effective." PharmaControl stated that both the FDA OTC Internal Analgesic, Antipyretic and Antirheumatic Panel and the Miscellaneous Internal Panel treated aspirin (acetylsalicylic acid) and sodium aspirn (sodium acetylsalicylate) as "regulatory synonyms." The company noted that both panels "placed aspirin in Category I, reaching the determination that this ingredient was generally recognized as safe and effective for OTC use as an internal analgesic." PharmaControl said "although sodium acetylsalicylate is not listed by name as a Category I active ingredient in either of the two panel reports, it is clear from panel minutes that both panels in their deliberations on aspirin specifically considered studies on sodium acetylsalicylate." PharmaControl has developed an oral soluble sodium aspirin produc which it has optioned to McNeil. The company has also developed an injectable form of sodium acetylsalicylate. PharmaControl President and CEO Max Tesler, MD, indicated firm is in the last stages "of negotiations with a major pharmaceutical company to give them the marketing rights for the [injectable] product."

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