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Posts Tagged ‘Food and Drug Administration’

The AP (http://tinyurl.com/long-lasting-zyprexa 12/15) reports Drugmaker Eli Lilly & Co said regulators have approved a longer-lasting version of its top-selling drug, the anti-psychotic Zyprexa.  The Food and Drug Administration approved Zyprexa Relprevv, an injection that can last up to four weeks, for the treatment of schizophrenia in adults.  Patients on Zyprexa currently take a pill daily. Lilly also makes a fast-acting injection of the drug that can be absorbed by the body in a few hours to treat agitation.  For the new version, patients will visit their doctors every two or four weeks to receive the injection, spokeswoman Janell Smith said.  She said the longer-lasting version makes it easier for patients to stay on the medication, and it allows doctors to track whether they’re doing that since they have to make office visits for the injections. 

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The AP ( 12/4 http://tinyurl.com/seroquel-xr-mdd) reported Pharmaceutical company AstraZeneca PLC has won U.S. approval for use of its schizophrenia drug Seroquel XR as an add-on treament for major depressive disorder.  But the London-based company said that the U.S. Food and Drug Administration has asked for more information before allowing the drug’s use as a single agent to treat major depressive disorder, or MDD.  Seroquel XR is an extended-release version of AstraZeneca’s schizophrenia medication Seroquel, a major seller for the company. It is already approved for bipolar disorder and schizophrenia.  AstraZeneca said it is evaluating the FDA’s request.  “AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course,” it said in a statement.

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