Botox, made by Allergan has had quite the ride the last couple of years. It is approved for use for migraine headaches in Europe. Dysport is a cheaper drug that was approved by the FDA, that does the same thing as does Botox. 
Botox Given Approval in the UK for Migraine Headache Relief
In October last year Allergan sued the FDA wanting the the label ban removed. There are also studies going on with Botox being able to shrink a prostate gland too.
Allergan Suing the FDA – Wants Off Label Ban for Botox Removed
The FDA has given approval for Botox for use with muscle spasms of the wrist and finger areas. The headache shots would be somewhere from $1000 to $2000 for a session of 30-40 shots around the head, neck and shoulders, ouch! the Mayo clinic has been testing the use of botox in their Phoenix, Arizona location. As the article from the New York Times mentions there’s marketing involved here too which is really not supposed to occur with drugs as it does with devices and the software business with the big hypes. BD
In public relations, it’s known as “seeding the market” — stirring up excitement for a forthcoming product or application.
“What concerns F.D.A. is that, if companies can promote off-label uses without submitting evidence showing the drug to be safe and effective, it potentially puts patients at risk and subverts the drug approval system,” Dr. Joshua M. Sharfstein, the principal deputy commissioner of the F.D.A., said in a phone interview about the case on Tuesday.
Without an independent determination by agency experts on the optimal doses and precautions for a particular drug treatment, he said, doctors can wind up prescribing medications without good evidence.
Except for the one misbranding charge, Allergan has denied the criminal and civil accusations, including those of kickbacks and fraud, said Caroline Van Hove, a company spokeswoman, adding that the allegations were not proved.
“I want to be clear that Allergan is not charged with misleading doctors or causing any patient harm,” Ms. Van Hove wrote in an e-mail to a reporter on Monday, “and we adamantly deny any implication that this occurred.”
Dr. Sharfstein of the F.D.A. said the Allergan settlement for off-label marketing would not influence the agency’s scientific review of the migraine application. “I think the approval should follow the evidence,” he said.
Millions of dollars are indeed at stake for Allergan.
After Fine, Botox Awaits F.D.A. Approval for Migraine - NYTimes.com
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