Johnson & Johnson Pharmaceutical Research & Development LLC, a unit of Johnson & Johnson (JNJ), announced on Tuesday that the U.S. Food and Drug Administration has asked for additional data to approve the company's new drug application for schizophrenia drug, paliperidone palmitate.
The FDA has outlined other issues that need to be addressed for granting approval to paliperidone palmitate. The agency does not require any additional studies.
The company's paliperidone palmitate is an investigational once-monthly atypical antipsychotic intramuscular injection for treating schizophrenia and preventing recurrence of its symptoms.
Paliperidone palmitate utilizes the NanoCrystal Technology patented by Elan Pharma International Ltd. Ireland, a subsidiary of Elan Corp. Plc (ELN).
Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals Inc.
JNJ closed Tuesday's regular trading session at $70.71, down 9 cents. In the after-hours, the shares further lost 6 cents.
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