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Block Drug's BC Powder

Executive Summary

Company will met with FDA at a May 19 OTC "feedback meeting" to discuss contribution of the adjuvant salicylamide to Block's analgesic product, which also contains aspirin and caffeine. Salicylamide, along with other adjuvants, are classified as Category III in analgesic TFM. Block gave agency a pharmacokinetic study to show that ingredient increases the plasma concentration of aspirin, and a protocol for a study on salicylamide's role in reducing pain to support moving the ingredient to Category I. The meeting will be held at 2:30 in Conference Room C of FDA's Parklawn Building.
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PS015532

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