FDA — authorised 10 September 2014
- Application: NDA200063
- Marketing authorisation holder: NALPROPION
- Local brand name: CONTRAVE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Naltrexone-Bupropion Combination on 10 September 2014
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 10 September 2014; FDA has authorised it.
NALPROPION holds the US marketing authorisation.