U.S. seeks more data for J&J schizophrenia drug
WASHINGTON (Reuters) - U.S. health regulators have called for more data before deciding whether a Johnson & Johnson experimental schizophrenia drug could be sold on the U.S. market, the company said on Tuesday.
But the Food and Drug Administration (FDA) did not ask for new clinical trials to be conducted, the health care company said.
The once-monthly injectable drug, know chemically as paliperidone palmitate, had been expected to help prop up the company's sales.
Johnson & Johnson said it received a so-called "complete response" letter from the FDA. The agency, by law, cannot comment publicly on letters that do not approve products.
Company officials said they were reviewing the FDA's letter and would work with the agency to answer any remaining questions.
Paliperidone palmitate is made with so-called "NanoCrystal" technology from Elan Corp.
Shares of Johnson & Johnson earlier closed down near flat at $70.71, while shares of Elan earlier closed down 1.2 percent at $14.08, both on the New York stock Exchange.
(Reporting by Susan Heavey)
