A subsidiary of diversified health care company
late Friday said that it has received an "approvable letter" from the Food and Drug Administration for its paliperidone extended-release tablets for the treatment of schizophrenia, requesting more information.
According to published reports, Johnson & Johnson's Pharmaceutical Research & Development unit said it is evaluating the letter and will work to resolve the FDA's questions in order to expedite approval of the drug.
The subsidiary applied for FDA approval of the tablets in November 2005. Further information about the nature of the FDA's questions was not disclosed, reports said.
Earlier this week the company's Centocor unit said that U.S. regulators
cleared Remicade for the treatment of adult patients with chronic severe plaque psoriasis, an inflammation of the skin.
Shares of the company rose 4 cents to close at $64.94; after hours they were recently up 15 cents to $65.09.