Mycobacterium Avium Complex Infection

• FDA approval · 2023-02-10
  FDA Approved: ARIKAYCE — Supplemental Application (Insmed Incorporated)

  FDA approved a supplemental application for ARIKAYCE (amikacin liposome inhalation suspension) from Insmed Incorporated. This action updates…

• FDA approval · 2021-12-17
  FDA Approved: RIFABUTIN — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved rifabutin under an original application for ANI Pharmaceuticals, Inc. (ANDA).

• FDA approval · 2021-09-15
  FDA Approved: RIFABUTIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Rifabutin submitted by Mylan Pharmaceuticals Inc. under NDA 050689.

• FDA approval · 2015-07-01
  FDA Approved: RIFABUTIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Rifabutin from Mylan Pharmaceuticals Inc., updating labeling and approved uses.