FDA holds back approval for J&J schizophrenia med

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
- read the report from the Wall Street Journal

Related Articles:
FDA won't expand Doribax use now
Johnson & Johnson - Top 15 R&D Budgets
J&J considers selling wound care division
J&J's consumer sales drive earnings growth