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Alias Born 09/14/2011

Re: None

Monday, 06/24/2013 1:50:02 PM

Monday, June 24, 2013 1:50:02 PM

Post# of 6072
I contacted CDER and asked if they could find out the status of Marqibo, since it was released close to 1 year ago. The answer below:

Dear Mr XXXXXX,

I contacted Talon Therapeutics directly for any available information. According to the firm, the product is currently being readied for commercial launch. However in the meantime, the firm is making the drug available on a case- by- case basis through a single-patient Investigational New Drug application (IND). This is a physician- initiated request to use an unapproved drug or other product for a single patient. For further information, please visit: www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm163982.htm.

Best regards,
Drug Information Specialist KC
Division of Drug Information
Center for Drug Evaluation and Research Food and Drug Administration

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