EMMA - Saudi Food and Drug Authority accepts Emmaus' Endari marketing authorization application

Emmaus Life Sciences ([[EMMA]] +0.7%) announces that its application for Marketing Authorization ((MA)) for Endari in the Kingdom of Saudi Arabia has been accepted by the Saudi Food and Drug Authority ((SFDA)).The SFDA's MA review and approval process typically takes 12 to 18 months.Endari, Emmaus' prescription grade L-glutamine oral powder, is approved by the U.S. FDA for treating sickle cell disease in adult and pediatric patients five years of age and older.During the review and approval process, Endari will be available to sickle cell disease patients on an early access basis to address an unmet medical need, the company said.

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Saudi Food and Drug Authority accepts Emmaus' Endari marketing authorization application