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PANCREATIN, PANCRELIPASE ARE CATEGORY I FOR OTC EXOCRINE PANCREATIC

Executive Summary

PANCREATIN, PANCRELIPASE ARE CATEGORY I FOR OTC EXOCRINE PANCREATIC insufficiency treatment following expert diagnosis, according to FDA's tentative final monograph (TFM), published in the Nov. 8 Federal Register. The agency's classification of the ingredients concurs with that of the OTC Miscellaneous Internal Drug Products Review Panel. FDA also agreed with the panel that hemicellulase is Category II for use in exocrine pancreatic insufficiency. The agency noted that it had received several comments objecting to the OTC availability of pancreatic extracts because the disease states leading to exocrine pancreatic insufficiency require physician diagnosis and treatment. FDA said once the insufficiency is diagnosed, a consumer can safely and effectively self-treat the condition. The agency added that because pancreatic extracts are not toxic at the recommended OTC dose and patients are able to self-monitor and adjust individualized dosage of the drug, there is no need to restrict the treatment to Rx status. FDA proposes that labeling of pancreatic extract products include a statement of the enzyme activity levels per dosage unit. In addition, the maximum daily recommended enzyme activity levels are to be based on the minimum levels established in the USP in addition to the gram amount. Comments on both the OTC exocrine pancreatic insufficiency drug products TFM and OTC drug products for nocturnal leg cramps TFM are due by Jan. 7. Comments on new data are due Jan. 8, 1987. New data was due by Nov. 10.
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PS009271

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