May 27, 2015
The U.S. Food and Drug Administration acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.'s antipsychotic Abilify despite remaining market exclusivity for the blockbuster product, a Maryland federal judge ruled Wednesday.
April 30, 2015
Otsuka Pharmaceutical Co. Ltd. won't be able to keep generic versions of its antipsychotic drug Abilify off the shelves, a Maryland federal judge said Wednesday, holding that the U.S. Food and Drug Administration correctly approved the generics despite exclusivity remaining for some of Abilify's uses.
April 28, 2015
In the face of objections from Otsuka Pharmaceutical Co. Ltd., the U.S. Food and Drug Administration approved the first generic versions of the antipsychotic drug Abilify on Tuesday, despite Otsuka still holding exclusivity for some of its uses.
April 20, 2015
The U.S. Food and Drug Administration on Monday asked a Maryland federal judge not to block it from approving generic versions of Otsuka Pharmaceutical Co. Ltd.'s mega-blockbuster Abilify, saying there is no basis to assume that such approvals would be improper, as the drugmaker has claimed.
April 15, 2015
Otsuka Pharmaceutical Co. Ltd. on Wednesday launched fresh litigation against the U.S. Food and Drug Administration, asking a Maryland federal judge to block regulators from clearing generic competition to its mega-blockbuster antipsychotic Abilify.
April 10, 2015
The U.S. Food and Drug Administration has rescinded approval for an exclusivity-threatening use of Otsuka Pharmaceutical Co. Ltd.'s blockbuster Abilify but still intends to approve generic versions, the Japanese drugmaker told a Maryland federal judge on Friday.
April 08, 2015
A Maryland federal judge on Wednesday rebuked the U.S. Food and Drug Administration over its attempt to derail high-profile litigation involving exclusivity for Otsuka Pharmaceutical Co. Ltd.'s blockbuster antipsychotic Abilify, accusing regulators of stalling as generic competition draws closer.
March 30, 2015
Otsuka Pharmaceutical Co. Ltd.'s unusual lawsuit against the U.S. Food and Drug Administration over a newly approved use of mega-blockbuster Abilify will test the powerful tactic of thwarting generic competition by securing clearance for treatment of rare diseases, attorneys say.
March 24, 2015
Otsuka Pharmaceutical Co. slammed the U.S. Food and Drug Administration Tuesday for expanding the scope of its antipsychotic drug Abilify to treat Tourette's syndrome in patients of all ages rather than only in children, calling it a ploy to admit generic versions when the company's patent expires next month.