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Over the Counter Today

Insight and analysis covering the nonprescription drugs, dietary supplement and personal care industries.

May 10, 2010

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“FDA finds OTC sleep-aid data lacking: Reuters reports FDA's determination that data on the combination of acetaminophen and diphenhydramine are insufficient to support a monograph indication for relief from sleeplessness due to aches and pains. The agency's recent letter, responding to a data submission from industry 15 years ago, could put the kibosh on claims made for Johnson & Johnson's Tylenol PM and Novartis' Excedrin PM. Our colleague Donald Riker at OTC Product News also blogs on the topic, looking at the science behind the ingredients...”

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