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Anticholinergic/sedative combos

Executive Summary

FDA rejects hearing requests and withdraws NDAs for Searle's Pro-Banthine with Phenobarbital and DuPont's Valpin with Phenobarbital. In Sept. 14 Federal Register notice, FDA said firms submitted no new data, but rather "relied on legal arguments," principally that they need more time to conduct studies ant that FDA is required to act on the combos as a class

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