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AHP's Alredase (tolrestat)

Executive Summary

The aldose reductase inhibitor will be considered by FDA's Endocrine & Metabolic Drugs Advisory Cmte. Sept. 11. Ayerst presented safety data on the drug to the cmte. in March prior to filing an NDA. The cmte. will also consider whether 2,4 dinitrophenol should be studied for use in weight reduction; and, on Sept. 12, will review Kendall McGaw's orphan drug Ucephan (benzoate phenylacetate) for treatment of urea cycle enzymopathies.
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PS010583

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