FDA Issues New Complete Response Letter

J0385349Pursuant to my posting earlier today, by coincidence, Johnson & Johnson announced the receipt of a Complete Response Letter.  It is worth noting that they provided no details about the contents of the letter, except to say that there were "questions" and that no further clinical studies were needed. 

This is the second Complete Response Letter that J&J has received this month, the first being for Doribax.   By comparison, the information in the press release issued today for the NDA for paliperidone palmitate was far less forthcoming than that of the earlier CRL received by the company for Doribax. 

Text of today’s press release:

FDA ISSUES COMPLETE RESPONSE LETTER FOR PALIPERIDONE PALMITATE FOR THE TREATMENT OF SCHIZOPHRENIA – Titusville, NJ (Aug 26, 2008) – Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional data before it will approve the company’s New Drug Application (NDA) for paliperidone palmitate, an investigational once-monthly atypical antipsychotic intramuscular injection for treating schizophrenia and preventing recurrence of its symptoms.

The letter outlined remaining questions that need to be addressed prior to granting approval for paliperidone palmitate. The agency does not require any additional studies.

J&JPRD is currently evaluating the FDA complete response and intends to work with the agency to resolve any outstanding questions. The NDA for paliperidone palmitate was submitted in October 2007.

Paliperidone palmitate utilizes the NanoCrystal® Technology patented by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc.

Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of Johnson & Johnson, the world’s most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the U.S. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

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