The USFDA said that it has achieved a year early the target set for 2017, to take action on 90% of the applications pending prior to the start of the Generic Drug User Fee Amendment Act (GDUFA) of 2012.
Emmaus Medical recently received FDA (The U.S. Food and Drug Administration) approval for sickle cell disease therapy Endari (L-gluitamine), ending two decades of drought for treatment of the disease and giving an alternative to the only other drug on the market, hydroxyurea.
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