FDA — authorised 7 August 1978
- Application: NDA017963
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: LOPRESSOR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lopressor in United States
FDA authorised Lopressor on 7 August 1978
Marketing authorisations
FDA — authorised 27 December 1989
- Application: NDA019786
- Marketing authorisation holder: NOVARTIS
- Local brand name: LOPRESSOR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 January 1992
- Application: NDA019962
- Marketing authorisation holder: MELINTA THERAP
- Local brand name: TOPROL-XL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 February 2010
- Application: ANDA077761
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Indication: Labeling
- Status: approved
FDA — authorised 28 June 2024
- Application: ANDA204106
- Marketing authorisation holder: NOVAST LABS
- Indication: Labeling
- Status: approved
The FDA approved Lopressor, a medication for hypertension and angina, on 28 June 2024. The approval was granted to NOVAST LABS through a standard expedited pathway. Lopressor is a beta-blocker that helps to lower blood pressure and reduce the frequency of angina attacks.
FDA — authorised 26 July 2024
- Application: ANDA214110
- Marketing authorisation holder: ZHEJIANG JUTAI PHARM
- Status: approved
FDA — authorised 8 January 2025
- Application: ANDA215789
- Marketing authorisation holder: SENORES PHARMS
- Status: approved
FDA — authorised 10 April 2025
- Application: NDA219373
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: LOPRESSOR
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 11 June 2025
- Application: ANDA078085
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
Hospira was granted marketing authorisation for Lopressor by the FDA on 11 June 2025. Lopressor is a medication used for its indication as per the approved labeling. The marketing authorisation was granted under the standard expedited pathway.
FDA — authorised 28 August 2025
- Application: NDA218698
- Marketing authorisation holder: XTM CONSULTING
- Local brand name: LOPRESSOR
- Indication: TABLET — ORAL
- Status: approved
Lopressor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Lopressor approved in United States?
Yes. FDA authorised it on 7 August 1978; FDA authorised it on 27 December 1989; FDA authorised it on 10 January 1992.
Who is the marketing authorisation holder for Lopressor in United States?
VALIDUS PHARMS holds the US marketing authorisation.