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Healthcare

UPDATE 1-US objects to AstraZeneca schizophrenia drug pitch

WASHINGTON, Dec 4 (Reuters) - U.S. regulators complained that an AstraZeneca PLC AZN.L sales representative suggested an unapproved use of the company's schizophrenia drug Seroquel to a physician, according to a letter released on Thursday.

The Food and Drug Administration, in a letter to the company, said an AstraZeneca representative told a doctor in January 2008 that Seroquel was approved for treating depression. The doctor then requested information to support the claim, and AstraZeneca sent a mailing that summarized research studies of Seroquel in depression, the FDA said.

Seroquel and Seroquel XR are not approved for treating depression.

“The representative and the mailing recommended or suggested a use for Seroquel and Seroquel XR that has not been approved by FDA, and thus created a new ‘intended use’ ... for which the products lack adequate directions,” the FDA letter said.

According to the FDA letter, AstraZeneca’s mailing said the company did not recommend Seroquel for uses not on the official prescribing information. But the agency said that disclaimer was “insufficient to mitigate the promotion” of a new use.

The agency asked the company to stop using any similar promotional material.

AstraZeneca spokeswoman Kirsten Evraire said the company “takes these allegations seriously, and we are conducting a full investigation.”

“Although the allegations related to one isolated incident, AstraZeneca is taking steps to reinforce” policies for sales representatives on appropriate interaction with physicians, Evraire said in an e-mail.

The FDA letter was dated Dec. 1 and posted on the FDA website on Thursdayhere. (Editing by Jeffrey Benkoe)

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