FDA — authorised 2 April 2019
- Application: ANDA209278
- Marketing authorisation holder: PENN LIFE
- Local brand name: CARMUSTINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 BEAM in United States
FDA authorised BEAM on 2 April 2019
Marketing authorisations
FDA — authorised 22 October 2020
- Application: ANDA213207
- Marketing authorisation holder: DR REDDYS
- Local brand name: CARMUSTINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 2022
- Application: ANDA211011
- Marketing authorisation holder: NOVAST LABS
- Local brand name: CARMUSTINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 May 2023
- Application: ANDA214814
- Marketing authorisation holder: MSN
- Local brand name: CARMUSTINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 October 2023
- Application: ANDA215730
- Marketing authorisation holder: ALEMBIC
- Local brand name: CARMUSTINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
BEAM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is BEAM approved in United States?
Yes. FDA authorised it on 2 April 2019; FDA authorised it on 22 October 2020; FDA authorised it on 21 June 2022.
Who is the marketing authorisation holder for BEAM in United States?
PENN LIFE holds the US marketing authorisation.