FDA — authorised 13 August 2014
- Application: NDA204569
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: BELSOMRA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Suvorexant 10 mg in United States
FDA authorised Suvorexant 10 mg on 13 August 2014
Marketing authorisations
FDA
- Status: approved
Suvorexant 10 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Suvorexant 10 mg approved in United States?
Yes. FDA authorised it on 13 August 2014; FDA has authorised it.
Who is the marketing authorisation holder for Suvorexant 10 mg in United States?
MERCK SHARP DOHME holds the US marketing authorisation.