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Pharmaceuticals / Submissions and Approvals

FDA Approves First New Sickle Cell Drug in 20 Years

July 11, 2017
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The FDA on Friday approved Endari, the first new drug in nearly 20 years to treat sickle cell anemia complications.

The L-glutamine oral powder, sponsored by Emmaus Medical, was approved for adults and children over 5 years old to reduce severe complications associated with the blood disorder. Previously, the only available treatment was hydroxyurea, approved by the FDA in 1998.

Though glutamine is currently sold as a nutritional supplement and a medical food, Emmaus’ L-glutamine will be produced and sold as a prescription drug.

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