Complicated Intra-abdominal Infection

• EMA approval · 2026-01-26
  EMA Authorised: Recarbrio (imipenem monohydrate;cilastatin sodium;relebactam monohydrate) — Merck Sharp & Dohme B.V.

  EMA authorised Recarbrio (imipenem/cilastatin/relebactam) for use in Gram-negative bacterial infections, including hospital-acquired/ventila…

• EMA approval · 2025-10-22
  EMA Authorised: Tygacil (tigecycline) — Pfizer Europe MA EEIG

  The European Medicines Agency authorised Tygacil (tigecycline) for use in bacterial infections, including complicated skin and soft tissue i…

• 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 · 2024-01-26
  FDA Approved: AVYCAZ — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for AVYCAZ (ceftazidime-avibactam) filed by Allergan, Inc.

• FDA approval · 2023-01-27
  FDA Approved: ERTAPENEM — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for ertapenem submitted by Eugia US LLC, authorizing changes to its approved labeling and/or ind…

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• FDA approval · 2022-08-18
  FDA Approved: MEROPENEM — Original Application (BROOKS STERISCIENCE LIMITED)

  FDA approves Brooks SterisScience Limited's original application for generic meropenem (Meropenem) for multiple susceptible bacterial infect…

• 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 · 2020-05-25
  FDA Approved: VABOMERE — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for VABOMERE (meropenem-vaborbactam) from Melinta Therapeutics to modify/expand its labeling.

• 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 · 2018-08-27
  FDA Approved: XERAVA — Original Application (Tetraphase Pharmaceuticals, Inc.)

  The FDA approved Xerava (eravacycline) from Tetraphase Pharmaceuticals in an original application for the treatment of complicated intra-abd…

• FDA approval · 2017-08-29
  FDA Approved: VABOMERE — Original Application (Melinta Therapeutics, LLC)

  FDA approved VABOMERE (meropenem-vaborbactam) from Melinta Therapeutics as an original application.

• FDA approval · 2014-12-19
  FDA Approved: ZERBAXA — Original Application (Merck Sharp & Dohme LLC)

  FDA approved ZERBAXA (ceftolozane and tazobactam) via Original Application for the treatment of complicated intra-abdominal infections and c…

• FDA approval · 2008-03-20
  FDA Approved: CEFEPIME — Original Application (Sagent Pharmaceuticals)

  FDA records the original approval of cefepime hydrochloride (cefepime) for Sagent Pharmaceuticals under an ANDA. The approval concerns a bro…