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US FDA Serves One Antacid/Analgesic Question For AdComm, Opens Tap On Hangover Discussion

Presentations at the US nonprescription drugs/drug safety joint advisory committee meeting will come from Bayer, marketer of the OTC brand synonymous with antacid/aspirin formulations, Alka-Seltzer, and from a firm that markets Blowfish, a caffeine/aspirin OTC indicated as a hangover remedy.

FDA is posing a single voting question for the upcoming advisory panel on the safety of OTC antacid/analgesic combinations for pain and acid indigestion from overindulgence with food or alcohol, but also is looking for a broader discussion on whether hangover is an appropriate OTC monograph indication.

In a joint meeting on April 4, the Nonprescription Drug and the Drug Safety and Risk Management advisory committees will...

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