The U.S. Department of Justice is investigating Allergan Inc.'s promotion of its blockbuster wrinkle smoother Botox for "off label" medical uses.
Allergan received a subpoena from the U.S. Attorney's Office for the Northern District of Georgia demanding that the company produce documents regarding its promotional and educational practices involving the use of the botulinum toxin-based drug for medical problems, it said.The company said it understood that the inquiry involved questions about the alleged use of Botox for the treatment of headaches.
Allergan is engaged in advanced clinical studies investigating the use of Botox for headaches. But the company does not have U.S. Food and Drug Administration approval to market the drug for that particular use.Because the FDA has approved Botox for a number of other medical problems, physicians may use their discretion to prescribe it for headaches, a so-called "off-label" use.
The inquiry appeared to be focused on whether Allergan was promoting the drug for use against headaches without FDA approval for such marketing.
More at LA Times
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