FDA — authorised 31 October 1991
- Application: NDA050662
- Marketing authorisation holder: ABBVIE
- Local brand name: BIAXIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Biaxin in United States
FDA authorised Biaxin on 31 October 1991
Marketing authorisations
FDA — authorised 23 December 1993
- Application: NDA050698
- Marketing authorisation holder: ABBVIE
- Local brand name: BIAXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 December 2010
- Application: ANDA065283
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 14 February 2023
- Application: ANDA065489
- Marketing authorisation holder: AUROBINDO
- Indication: Labeling
- Status: approved
FDA — authorised 31 May 2023
- Application: ANDA203584
- Marketing authorisation holder: HEC PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 17 August 2023
- Application: ANDA208987
- Marketing authorisation holder: SUNSHINE
- Indication: Labeling
- Status: approved
FDA — authorised 31 July 2024
- Application: NDA215152
- Marketing authorisation holder: PHATHOM
- Indication: Labeling
- Status: approved
The FDA approved Biaxin, manufactured by PHATHOM, on 31 July 2024. The approval was granted under the standard expedited pathway. The marketing authorisation holder is PHATHOM, and the application number is NDA215152.
Biaxin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Biaxin approved in United States?
Yes. FDA authorised it on 31 October 1991; FDA authorised it on 23 December 1993; FDA authorised it on 22 December 2010.
Who is the marketing authorisation holder for Biaxin in United States?
ABBVIE holds the US marketing authorisation.