FDA Asks for Characterization Data in ANDAs for Risperdal Generics

Applications for generics of Johnson & Johnson’s Risperdal should contain characterization data on the reference product and the copycat version, the FDA says.

In a draft guidance document released Monday, the FDA tells generics makers of the antipsychotic, which treats schizophrenia, to provide data on the polymer composition, weight distribution, molecular weight, and the polylactide-coglycolide architecture of the candidate and reference product.

The FDA notifies generics makers of the possibility that the agency may still request additional characterization data during the ANDA review.