Otsuka Sues FDA for Illegally Broadening Drug Indications

March 26, 2015

Japan's Otsuka Pharmaceuticals is suing the U.S. FDA, claiming the agency illegally broadened the indication for its top-selling Abilify antipsychotic, opening the door to generic competition in the process.

According to the WSJ, the FDA approved Abilify for treating children with Tourette Syndrome last December, a move which delayed generics because the new indication gave Otsuka another seven years of exclusive marketing rights under an orphan designation.

Last month, the FDA notified Otsuka that the added indication for treating Tourette Syndrome would apply to adults as well as children.

By broadening Abilify's indication to include adults, Otsuka argues the FDA will trigger a labeling change that will allow generic competition.

Otsuka argues that the FDA is not allowed to approve a drug for an indication which a drug maker did not apply. The FDA is claiming the approval was simply correcting a previous error.

Read the WSJ blog