David Baxter PhD
Late Founder
U.S. panel suggests limited approval for antipsychotic drug
CBC News
Tuesday, April 7, 2009
The U.S. Food and Drug Administration should consider approving a drug for people with schizophrenia who don't respond to other treatments, an advisory panel said Tuesday.
The panel voted 8-2 to advise the FDA to make the antipsychotic drug sertindole, sold as Serdolect, available in some cases. But panellists voted 12-1 against recommending it for patients with schizophrenia in general.
Three people abstained from voting on the limited recommendation at the meeting in Silver Spring, Md.
The drug carries potential heart-related risks, making it unsuitable for more general use.
The FDA will consider the panel's recommendations and is expected to decide by May 15. The regulator usually follows the advice of the panels.
The drug's manufacturer, Lundbeck, claims it prevents suicidal-related thoughts or actions better than other antipsychotic drugs. The panel rejected that claim.
Health Canada has not approved the drug, which is available in Europe.
CBC News
Tuesday, April 7, 2009
The U.S. Food and Drug Administration should consider approving a drug for people with schizophrenia who don't respond to other treatments, an advisory panel said Tuesday.
The panel voted 8-2 to advise the FDA to make the antipsychotic drug sertindole, sold as Serdolect, available in some cases. But panellists voted 12-1 against recommending it for patients with schizophrenia in general.
Three people abstained from voting on the limited recommendation at the meeting in Silver Spring, Md.
The drug carries potential heart-related risks, making it unsuitable for more general use.
The FDA will consider the panel's recommendations and is expected to decide by May 15. The regulator usually follows the advice of the panels.
The drug's manufacturer, Lundbeck, claims it prevents suicidal-related thoughts or actions better than other antipsychotic drugs. The panel rejected that claim.
Health Canada has not approved the drug, which is available in Europe.
