March 31, 2008
Otsuka American Pharmaceutical Inc., the U.S. subsidiary of Japanese pharmaceutical manufacturer Otsuka Pharmaceutical Co., Ltd., will pay more than $4 million to resolve allegations that it marketed Abilify, an atypical antipsychotic drug, for “off-label” uses.
The Corporate Crime Reporter said that the Food and Drug Administration had approved Abilify to treat adult schizophrenia and bi-polar disorder but that the company promoted it for pediatric use. While physicians are allowed to prescribe drugs for “off-label” uses, companies are prohibited from promoting drugs for uses that aren’t FDA approved.
The whistleblower in the suit will receive $348,000 as his relator’s share.