Salix stock surges 5% despite FDA warning about ads
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MORRISVILLE, N.C. – Recent advertising for a newly approved drug to treat acid reflux is “false or misleading,” the U.S. Food and Drug Administration told Salix Pharmaceuticals (Nasdaq” SLXP) on Tuesday.
In a “warning letter” posted on the FDA Web site, the drug regulatory agency said Salix omitted and minimized “risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”
Salix, which focuses on gastrointestinal drugs, received FDA approval for Metozolv last September. It is a treatment for a diabetic condition called gastroparesis, in which the stomach has trouble emptying, and acid reflux known as gastroesophageal refulx disease.
Salix shares were unaffected by the news, however. On the day, Salix climbed nearly 5 percent, or $1.74, to close at $37.41. Shares traded as high as $37.60.
Salix received FDA approval for another drug last week. That news sent Salix shares to a 52-week high of $38. Its 52-week low is $8.78.
Metozolv ODT is intended to help patients who have trouble swallowing, do not have water available when treatment is required, or need a portable medication, according to Salix.
In its letter, the FDA said the advertising “misleadingly broaden the indication of Metozolv ODT by suggesting that the drug is useful in a broader range of conditions and patients than has been demonstrated by substantial evidence or substantial clinical experience.”
“Your failure to reveal material information regarding the risks associated with Metozolv ODT in an array of both professionally-directed and consumer-directed promotional materials, including pieces not discussed within this letter, is extremely concerning from a public health perspective,” the FDA added.
The FDA also said Salix did not submit the materials for review.
“FDA regulations require companies to submit specimens of any labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product,” the agency wrote.
“Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice,” the letter concluded.
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