J&J’s Risperdal Consta Gets Complete Response for Bipolar Indication

The FDA issued a complete response letter to Johnson & Johnson (J&J) on its long-acting injectable antipsychotic Risperdal Consta for the adjunctive maintenance treatment of patients with frequent relapses of bipolar disorder. The letter “outlined questions that need to be addressed prior to granting approval for the new indication, but did not request additional studies,” J&J says in a statement. The complete response letter is a setback for the company as it tries to build up the number of approved indications for the product before potential competitors reach the market, such as Eli Lilly’s monthly injectable formulation of Zyprexa (olanzapine pamoate).
Drug Industry Daily