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Drug Development
U.S. FDA won't meet PDUFA date on Hylenex new drug application
October 25th, 2005
Halozyme Therapeutics, Inc., (HTI), announced that during discussions with the U.S. Food & Drug Administration (FDA) regarding Halozyme's new drug application (NDA) for Hylenex recombinant (hyaluronidase human injection), the agency told the company that it would be unable to meet its Prescription Drug User Fee Act (PDUFA) action date for Hylenex.
The agency stated that it is still reviewing the application.
The company is currently unable to anticipate the timing of FDA's first action but hopes it will be soon.
Halozyme is a biopharmaceutical company dedicated to developing and commercializing recombinant human...
Source: cancer weekly (2005-10-25)
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