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J&J's Paliperidone Gets "Complete Response" Letter From FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

No more studies are required, but FDA outlined questions that need to be addressed, according to J&J

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Janssen studies higher initiation dose for paliperidone palmitate

J&J's Janssen unit is conducting an additional Phase III trial of paliperidone palmitate to further assess a 150 mg equivalent initiation dose of the injectable long-acting form of Invega (paliperidone) for treatment of schizophrenia. The firm announced results of a 13-week study Dec. 10 showing paliperidone palmitate to have a statistically significant symptom control compared to placebo at all doses tested when given every 4 weeks for 13 weeks with a 150 mg eq. initiation dose. Subsequent doses were either 25 mg, 100 mg, or 150 mg eq. An earlier dose-ranging trial using a much lower initiation dose of 50 mg eq. failed to show non-inferiority to risperidone LAT. J&J said Oct. 14 that the drug's launch might have to be pushed back to 2010 to address an FDA "complete response" requesting a re-analysis of a subset of the data (1Pharmaceutical Approvals Monthly September 2008, p. 16)

J&J’s Doribax Is Subject Of FDA’s First "Complete Response" To An NDA

FDA is seeking additional information on Johnson & Johnson's Doribax (doripenem) prior to approving the antibiotic for the treatment of hospital-acquired pneumonia, including ventilator-associated pneumonia, the company announced Aug. 21

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