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Phenylpropanolamine patch

Executive Summary

Lewisville, Texas-based Bio-American's ANDA suitability petition for a 150 mg phenylpropanolamine patch for weight loss denied by FDA Oct. 7. Noting that phenylpropanolamine is not generally recognized as safe and effective for weight loss, the agency explained that ANDA petition route cannot be used unless the final monograph on OTC weight loss products, which has not yet been issued, recognizes the 150 mg strength of the ingredient. Weight loss panel recommended that only a 75 mg strength be listed as safe and effective for weight loss.

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