Otsuka Pharmaceutical neurology news

The U.S. District Court for the District of Maryland granted FDA’s motion for summary judgment in a case filed by Otsuka alleging that the agency unlawfully approved generic versions of Otsuka’s Abilify aripiprazole. Otsuka claimed that the neurology drug is eligible for seven years of market exclusivity, until December 2021, due to its Orphan Drug status and approval in December 2014 to treat Tourette’s syndrome in children and adolescents. The court ruled in favor of FDA’s decision that the agency is able to approve generic versions of the neurology drug with “carved out protected labeling relating to Tourette’s disorder in pediatric patients.” ...