Otsuka settles Abilify allegations for $4 million

TOKYO Otsuka Pharmaceuticals has agreed to pay $4 million to resolve allegations that it marketed its schizophrenia drug Abilify for off-label uses with Bristol-Myers Squibb, according to published reports.

Squibb settled its issue with Abilify back in September by agreeing to pay $515 million to settle allegations that it overcharged the government for drugs and promoted medicine like Abilify for unapproved uses.

The accusations came from the Justice Department, which stated that the companies of promoting the drug for use in children, and as a remedy for dementia, without FDA approval. Now, the drug is required to carry a black-box warning for use in dementia-related psychosis.

Otsuka will pay the government about $2.3 million and the remainder to states’ Medicaid programs, the company said in a statement. It agreed to a corporate integrity agreement, without specifying the length of the compliance and monitoring pledged. The agreement requires the company to maintain compliance programs to monitor business practices.

Over 12.5 million prescriptions have been written as of June 2007 for Abilify, according to IMS.