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Endari FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved July 7, 2017)
Brand name: Endari
Generic name: L-glutamine
Dosage form: Oral Powder
Company: Emmaus Life Sciences Inc.
Treatment for: Sickle Cell Anemia

Endari (L-glutamine) is orally-administered pharmaceutical grade L-glutamine (PGLG), an amino acid formulation to relieve pain, swelling and other complications of sickle cell anemia.

Development timeline for Endari

DateArticle
Jul  8, 2017Approval FDA Approves Endari (L-glutamine oral powder) for Sickle Cell Disease
May 24, 2017FDA Advisory Committee Recommends Approval of Endari from Emmaus Life Sciences for the Treatment of Sickle Cell Disease
Nov  8, 2016Emmaus’ New Drug Application for Sickle Cell Disease Accepted for Review by FDA

Further information

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