FDA holds hearing on OTC drug review process; accepting comments until May 12
According to FDA's Federal Register Notice, FDA seeks comments on the strengths and weaknesses of the existing OTC review process, modernization concepts, and modification of or alternatives to the existing OTC review process. FDA apparently believes …
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FDA panel shoots down OTC Singulair
Merck's bid to resurrect Singulair faced a setback today, as an FDA advisory panel voted 11-4 against making the drug available over-the-counter. The drugmaker had submitted Singulair as an OTC remedy for hay fever and upper respiratory allergy …
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FDA Clears OTC Flonase Nasal Spray for Allergy Relief
The US Food and Drug Administration (FDA) has approved over-the-counter (OTC) fluticasone propionate 50 mcg nasal spray (Flonase Allergy Relief, GlaxoSmithKline) for treatment of hay fever or upper respiratory allergies, the company announced …
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