Allergan said it has received a subpoena for documents related to the promotion of its anti-wrinkle injection Botox.
The subpoena from the Department of Justice (DOJ), US Attorney's Office for the Northern District of Georgia, broadly requests Allergan documents regarding promotional, educational and other activities.
According to Allergan, the nature of the inquiry involves questions regarding alleged off-label promotion of the drug for the treatment of headache.
Allergan is currently in Phase III studies, investigating the use of Botox as a treatment for headache, however the drug is not currently approved by the FDA for this use.
Doctors may use their discretion in prescribing drugs for off-label uses however it is illegal for manufacturers to promote their products for indications not approved by the FDA.
Allergan said in a statement that its policy was to promote its products "only in a manner consistent with the FDA-approved product labeling," as well as with all laws and regulations.
The Botox-maker said it will fully cooperate with the DOJ to satisfactorily address “any and all” questions regarding the matter.
In 2007, Botox sales were $1.2 billion, representing about one-third of Allergan's total $3.9 billion in sales. Professional advertising for Botox is handled by Pacific Communications.