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Executive Summary

POTASSIUM CHLORIDE CONTROLLED RELEASE ANDA REQUIREMENTS do not include clinical studies, FDA indicated in response to a petition submitted by Alra Laboratories. In February 1985, Alra requested exemption from doing gastrointestinal toxicity studies in monkeys and clinical studies in 50 to 100 humans in order to file an ANDA for 8 mEq and 10 mEq potassium chloride slow release tablets. FDA responded four months later that Alra's petition "is now moot." Citing the Waxman/Hatch law, FDA Center for Drugs & Biologics Office of Standards Director Peter Rheinstein, MD, stated that "under the provisions of the new legislation, companies that previously were required to submit full NDAs or paper NDAs for post-1962 drug products may now submit ANDAs without clinical or toxicological safety and effectiveness data provided they comply with all requirements of the statute." The D.C. law firm Hyman, Phelps & McNamara recently petitioned FDA to issue guidance on conditions for approval of potassium chloride controlled release products ("The Pink Sheet" Nov. 10, T&G-7). The firm requested FDA to require that human endoscopic and animal ulcerogenicity studies be conducted as part of ANDAs for those products. There are currently no approved ANDAs for controlled release potassium chloride. One issue in the approval of such products is bioequivalence determinations. FDA is reviewing statistical methods to evaluate bioequivalence. Alra Labs, founded in Gurnee, Illinois in 1980, has six prescription and eight OTC products on the market. They include the laxative Alramucil, (psyllium husk) the potassium products K Care Powder, K Care ET (effervescent tablet), and Gelpirin, an acetaminophen/aspirin product that Alra acquired with the purchase of Schuemann Labs in 1982. Alra began submitting ANDAs to FDA in 1985 and says it currently has 18-19 applications pending.

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