Ambien Not Sleepwalking Through Scrutiny; Label Warnings Updated
Sanofi's sleeping pill has been revised once again in an update that also limits the recommended dosing.
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CDER officials explain the rationale behind new labeling on zolpidem-containing immediate- and controlled-release products that halves the recommended dose for women. Labeling changes include a new precaution against next-day driving following use of Sanofi’s Ambien CR.
Rep. Patrick Kennedy (D-R.I.) says he will check himself into the Mayo Clinic for rehab after he ran into a security barrier in Washington, D.C. May. When Capitol Police picked up the disoriented congressman at 2:45 a.m., he claimed he was headed to the Capitol for a vote. In a statement, Kennedy maintained that he was not under the influence of alcohol at the time of the incident, but admitted to having taken Sanofi-Aventis' insomnia therapy Ambien and Wyeth's antihistamine Phenergan. A recently filed class action lawsuit alleges Sanofi failed to adequately warn patients of risk of sleep walking and eating with Ambien (1"The Pink Sheet" March 20,2006, p. 18)...
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.