Wednesday, August 02, 2017 5:39:41 AM
The company reported on July 18, 2017, it was notified by the FDA, that the Company’s New Drug Application (“NDA”) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (“AGHD”) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.
http://tradersnewssource.com/aezs/
WHAT IS PDUFA?:
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
BOTTOM LINE: It's going to hit the U.S. market first and soon.
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