FDAnews Drug Daily Bulletin

The FDA has asked for additional data from Johnson & Johnson (J&J) before it will approve the company’s NDA for a once-monthly injectable formulation of its atypical antipsychotic Invega.

In the letter, the agency outlines remaining questions that need to be addressed before it approves the drug. The agency does not require any additional studies, according to J&J.

The new formulation is paliperidone palmitate, a long-acting ester of Invega (paliperidone). A trade name for the drug, which will treat schizophrenia and prevent the recurrence of its symptoms, has not been finalized.

The company said it is evaluating the complete response and intends to work with the agency to resolve any outstanding questions. The NDA for paliperidone palmitate was submitted last October.

J&J launched Invega early last year. The product is a metabolite of Risperdal (risperidone), another atypical antipsychotic drug.

Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, a division of J&J’s Ortho-McNeil-Janssen Pharmaceuticals.