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Belsomra FDA Approval History

FDA Approved: Yes (First approved August 13, 2014)
Brand name: Belsomra
Generic name: suvorexant
Dosage form: Tablets
Company: Merck
Treatment for: Insomnia

Belsomra (suvorexant) is an orexin receptor antagonist for use in patients with difficulty falling or staying asleep (insomnia).

Development timeline for Belsomra

DateArticle
Aug 13, 2014Approval FDA Approves Belsomra (suvorexant) for Insomnia
Jul  1, 2013Merck Receives Complete Response Letter for Suvorexant, Merck’s Investigational Medicine for Insomnia
May 22, 2013Merck Statement on FDA Advisory Committee Meeting for Suvorexant
Nov  8, 2012Merck Announces FDA Acceptance of New Drug Application for Suvorexant, an Investigational Insomnia Medicine

See also

Belsomra (suvorexant) Consumer information

Further information

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