Complicated Urinary Tract 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…

• FDA approval · 2025-10-22
  FDA Approved: CONTEPO — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Contepo (fosfomycin disodium) from Meitheal Pharmaceuticals as a new intravenous antibiotic under NDA212271 for the treatme…

• FDA approval · 2025-06-23
  FDA Approved: MEROPENEM — Original Application (BROOKS STERISCIENCE LIMITED)

  FDA approved the original application for a generic meropenem product manufactured by Brooks SterisScience Limited.

• 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 · 2024-06-24
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium by Sandoz Inc to support changes to the approved gener…

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• 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 · 2023-12-11
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)

  FDA approved an Original Application for amoxicillin and clavulanate potassium (amoxicillin/clavulanate) as a generic antibiotic formulation…

• FDA approval · 2023-02-10
  FDA Approved: ZEMDRI (PLAZOMICIN) — Supplemental Application (Cipla Therapeutics Inc.)

  FDA approved a supplemental application for ZemdrI (plazomicin) from Cipla Therapeutics Inc.

• FDA approval · 2021-02-16
  FDA Approved: PIPERACILLIN, TAZOBACTAM — Original Application (Sagent Pharmaceuticals)

  FDA approves Sagent Pharmaceuticals' generic Piperacillin-tazobactam for intravenous use under Original Application, enabling a generic vers…

• FDA approval · 2020-07-15
  FDA Approved: ZEMDRI (PLAZOMICIN) — Supplemental Application (Cipla Therapeutics Inc.)

  FDA approved a supplemental application for ZemdrI (plazomicin) submitted by Cipla Therapeutics Inc.

• 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 · 2019-11-14
  FDA Approved: FETROJA — Original Application (Shionogi Inc.)

  The FDA approves Fetroja (cefiderocol sulfate tosylate) from Shionogi in an Original New Drug Application for the treatment of complicated u…

• 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 · 2018-06-25
  FDA Approved: ZEMDRI (PLAZOMICIN) — Original Application (Cipla Therapeutics Inc.)

  FDA approved ZemdrI (plazomicin) under an original NDA from Cipla Therapeutics Inc. as a new antibiotic for complicated urinary tract infect…

• 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…