Allergan Inc. said late Monday that it received a subpoena from federal officials for documents relating to its flagship Botox drug.
The Irvine drug maker said the request, which came out of the U.S. Attorney’s Office for the Northern District of Georgia, covers materials related to promotional, educational and other activities for Botox.
Allergan said it believes that the subpoena involves questions relating to off-label use of Botox for headaches.
Allergan is in late-stage clinical trials for Botox as a headache treatment. Headache is not a Food and Drug Administration-cleared use for the product. But once a drug is approved by the FDA for any use, doctors can prescribe it for other conditions.
Allergan said it will fully cooperate with authorities and provide updates as it responds to the subpoena.
In a statement, Allergan said it was its policy to promote its products only in a manner consistent with FDA-approved product labeling.
