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Dayvigo FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved December 20, 2019)
Brand name: Dayvigo
Generic name: lemborexant
Dosage form: Tablets
Company: Eisai Inc.
Treatment for: Insomnia

Dayvigo (lemborexant) is dual orexin receptor antagonist (DORA) for the treatment of insomnia.

Development timeline for Dayvigo

Dec 23, 2019Approval FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients
Mar 12, 2019Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
Jan 15, 2019New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States

Further information

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