The FDA sent the drugmaker a warning letter after learning that a sales rep this past January suggested to physician that the Seroquel antipsychotic could be used to treat major depressive disorder, which would be an unapproved use.

After getting the pitch, the doc requested info to support the claim, and AstraZeneca mailed a thick packet that summarized research studies of Seroquel in depression, according to the FDA, which characterized the move as creating a new ‘intended use.’

According to the FDA letter, AstraZeneca’s material indicated the drugmaker did not recommend Seroquel for unapproved uses, but the FDA maintained the disclaimer was “insufficient to mitigate the promotion” of a new use (here is the letter and the material sent to the doc).

An AstraZeneca spokeswoman writes us to say the drugmaker “takes these allegations seriously and we are conducting a full investigation. We have a robust compliance program that calls for responsible sales and marketing practices that comply with applicable laws, regulations and industry standards, as well as AstraZeneca internal policies.

“AstraZeneca has policies and procedures in place that provide direction to its employees about the appropriate promotion of our products and the appropriate handling of requests from physicians for clinical information about our products. Although the allegations related to one isolated incident, AstraZeneca is taking steps to reinforce with the sales force the application of relevant AstraZeneca policies and standards, to continue to reinforce appropriate interactions with physicians.”