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The move brings FDA one step closer to getting products containing oral phenylephrine pulled from stores. FDA officials said an agency review of the available data found…
Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into approval during a sweeping FDA review begun in 1972. It has been sold in various forms for more than ...
Last October, a few weeks after the FDA advisory committee’s conclusion, CVS Health announced that the pharmacy chain would be removing certain phenylephrine products from stores. In a statement ...
The US Food and Drug Administration announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter decongestants – from the market, citing evidence ...
After that, the FDA will make a final decision on whether to remove products that contain phenylephrine. However, based on what the FDA has said (and what the evidence suggests), the medication is ...
In addition to the review, the FDA held a meeting of the Nonprescription Drug Advisory Committee to evaluate new evidence regarding phenylephrine's effectiveness. Based on the committee's ...
But many doctors have questioned phenylephrine’s effectiveness for years. These products generated nearly $1.8 billion in sales last year alone, according to data from the FDA that was presented ...
The panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise. The panel vote ...