The FDA has put up at least a temporary roadblock to J&J's schizophrenia drug paliperidone palmitate. A once-monthly injectable with the same active ingredient as Invega, a newly approved antipsychotic, the agency says it will need more information on the therapy before they can give it the stamp of approval. But it might not present a lengthy delay. J&J noted that the FDA is not asking for a new trial and says it will work with the FDA in answering all of its questions. The therapy uses technology from Elan, which stands to gain from an approval.
- check out the Johnson & Johnson release [1]
- read the report [2] from the Wall Street Journal
Related Articles:
FDA won't expand Doribax use now [3]
Johnson & Johnson - Top 15 R&D Budgets [4]
J&J considers selling wound care division [5]
J&J's consumer sales drive earnings growth [6]
Links:
[1] http://www.fiercebiotech.com/press-releases/fda-issues-approvable-letter-risperdal-treat-adolescents-schizophrenia-and-children-a
[2] http://online.wsj.com/article/SB121978391419874045.html?mod=googlenews_wsj
[3] http://www.fiercepharma.com/story/fda-wont-expand-doribax-use-now/2008-08-22
[4] http://www.fiercebiotech.com/special-reports/2-johnson-johnson-top-15-r-d-budgets
[5] http://www.fiercepharma.com/story/johnson-johnson-considers-selling-part-ethicon/2008-07-02
[6] http://www.fiercepharma.com/story/j-js-consumer-sales-drive-earnings-growth/2008-07-15