And the FDA sent a warning letter to Sanofi-Aventis SA accusing the French drugmaker of distributing misleading promotional material on its Uroxatral treatment for urinary problems caused by an enlarged prostate. At issue is a promotional card that touts the benefits of Uroxatral on the front, but only lists proper use of the medicine, risks associated with the drug, and those who should not be taking it, on the back. While noting that the use and risk information is included, the FDA warning letter said the so-called tent card is designed to be adhered to a flat surface, such as a pharmacy counter, "and as a practical matter, viewers of the front side of the card are unlikely to be able to view the back side of the card once it is stuck in place."
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|Title Annotation:||FDA ROUNDUP|
|Article Type:||Brief article|
|Date:||Nov 2, 2009|
|Previous Article:||In other action, the FDA confirmed that Shire Plc's attention-deficit hyperactivity drug was entitled to five years of exclusivity.|
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