Ventilator-associated Pneumonia

• EMA approval · 2026-03-23
  EMA Authorised: Vaborem (meropenem trihydrate;vaborbactam) — Menarini International Operations Luxembourg S.A.

  The European Medicines Agency authorised Vaborem, a meropenem trihydrate and vaborbactam combination, for use in several infections. It cove…

• 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 · 2025-02-28
  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…

• EMA approval · 2024-03-22
  EMA Authorised: Exblifep (cefepime dihydrochloride monohydrate;Enmetazobactam) — Advanz Pharma Limited

  Exblifep has been authorised for multiple infections including urinary tract infections, pyelonephritis, healthcare-associated pneumonia, an…

• 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…

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• 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 · 2014-03-13
  FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental labeling application for VIBATIV (telavancin hydrochloride) submitted by Cumberland Pharmaceuticals. The approva…

• FDA approval · 2013-12-12
  FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for Vibativ (telavancin hydrochloride) from Cumberland Pharmaceuticals Inc.

• 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 …