Hospital-acquired Pneumonia

• FDA approval · 2025-02-28
  FDA Approved: AVYCAZ — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for AVYCAZ (ceftazidime-avibactam) from Allergan, Inc., authorizing changes to the approved labeling…

• FDA approval · 2024-10-10
  FDA Approved: LINEZOLID — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's original ANDA for LINEZOLID (linezolid), making a generic linezolid available in the U.S. fo…

• FDA approval · 2024-08-22
  FDA Approved: LINEZOLID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for LINEZOLID (linezolid); the approval finalizes changes to the …

• FDA approval · 2022-10-31
  FDA Approved: LINEZOLID — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' LINEZOLID generic under an Original Abbreviated New Drug Application (ANDA 211813). The approval covers…

• FDA approval · 2022-02-17
  FDA Approved: LINEZOLID — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Linezolid submitted by Hospira, Inc. under NDA206473.

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• FDA approval · 2021-07-29
  FDA Approved: ZOSYN IN GALAXY CONTAINERS — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application to allow Zosyn (piperacillin/tazobactam) to be supplied in Galaxy containers, by Wyeth Pharmaceutica…

• FDA approval · 2020-02-20
  FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for VIBATIV (telavancin hydrochloride) from Cumberland Pharmaceuticals Inc. The approval indicates t…

• FDA approval · 2019-07-16
  FDA Approved: RECARBRIO — Original Application (Merck Sharp & Dohme LLC)

  FDA approved RECARBRIO (imipenem/cilastatin/relebactam) under NDA 212819 from Merck Sharp & Dohme LLC, marking the original approval of this…

• FDA approval · 2019-06-03
  FDA Approved: ZERBAXA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ZERBAXA (ceftolozane and tazobactam) from Merck, resulting in changes to the product labeling.

• FDA approval · 2019-03-14
  FDA Approved: AVYCAZ — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for AVYCAZ (ceftazidime-avibactam) that updates labeling in connection with the supplement.

• FDA approval · 2016-10-26
  FDA Approved: ZERBAXA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ZERBAXA (ceftolozane/tazobactam) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2013-02-01
  FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for VIBATIV (telavancin hydrochloride) from Cumberland Pharmaceuticals, updating the labeling under …