Pneumonia

• FDA approval · 2026-04-07
  FDA Approved: CEFEPIME HYDROCHLORIDE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application from B. Braun Medical Inc. for Cefepime hydrochloride and dextrose, adding this formulation under th…

• 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…

• FDA approval · 2026-03-11
  FDA Approved: MEROPENEM — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Meropenem by Sandoz Inc, resulting in updated regulatory status for the product.

• EMA approval · 2026-02-05
  EMA Authorised: Prevenar 13 (Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F) — Pfizer Europe MA EEIG

  EMA authorised Prevenar 13, a 13-valent pneumococcal conjugate vaccine, for immunization against pneumococcal infections in the EU. The vacc…

• EMA approval · 2025-11-14
  EMA Authorised: Zavicefta (avibactam sodium;ceftazidime pentahydrate) — Pfizer Ireland Pharmaceuticals Unlimited Company

  The EMA authorised Zavicefta (avibactam sodium and ceftazidime pentahydrate) for treatment of pneumonia, soft tissue infections, urinary tra…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2025-08-21
  FDA Approved: MEROPENEM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Meropenem submitted by BluePoint Laboratories (ANDA205883), confirming approval of a supplementa…

• 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 · 2025-05-29
  FDA Approved: LINEZOLID — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for LINEZOLID submitted by Hospira, Inc.

• FDA approval · 2024-11-19
  FDA Approved: ZOSYN IN GALAXY CONTAINERS — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application to allow Zosyn in Galaxy containers (piperacillin/tazobactam), a packaging/formulation change from W…

• FDA approval · 2024-07-22
  FDA Approved: MEROPENEM — Original Application (Qilu Antibiotics Pharmaceutical Co., Ltd.)

  FDA approved the original application for Meropenem from Qilu Antibiotics Pharmaceutical Co., Ltd., authorizing sale of a generic Meropenem …

• FDA approval · 2024-05-01
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Civica, Inc. for Piperacillin and Tazobactam (piperacillin/tazobactam).

• FDA approval · 2024-05-01
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental ANDA for Piperacillin and Tazobactam (piperacillin sodium and tazobactam sodium) manufactured by Eugia US LLC.

• FDA approval · 2024-04-25
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a Supplemental Application for Amoxicillin and clavulanate potassium by NorthStar Rx LLC, indicating a modification to an exist…

• FDA approval · 2024-04-25
  FDA Approved: AMOXICILLIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amoxicillin submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2024-04-24
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2023-11-21
  FDA Approved: LINEZOLID — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Linezolid (generic linezolid) under ANDA 211813. This action confirms appr…

• FDA approval · 2023-10-12
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Eugia US LLC)

  FDA approved the original abbreviated new drug application for piperacillin and tazobactam, a combination antibiotic manufactured by Eugia U…

• FDA approval · 2022-11-02
  FDA Approved: AMOXICILLIN — Supplemental Application (USAntibiotics, LLC)

  FDA approved a supplemental application for Amoxicillin submitted by USAntibiotics, LLC.

• 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 · 2022-03-18
  FDA Approved: CEFEPIME HYDROCHLORIDE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application for Cefepime hydrochloride and dextrose from B. Braun Medical Inc.

• FDA approval · 2022-02-23
  FDA Approved: LINEZOLID — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for LINEZOLID by Ascend Laboratories, LLC. The action approves changes to the product's labeling for…

• 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.

• FDA approval · 2021-11-18
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved vancomycin hydrochloride as a generic drug under an Original Application from Slate Run Pharmaceuticals, LLC.

• FDA approval · 2021-11-12
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (Plano Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Vancomycin hydrochloride by Plano Pharmaceuticals Inc., approving changes to the approved dr…

• FDA approval · 2021-10-26
  FDA Approved: ZYVOX — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Zyvox (linezolid) from Pharmacia & Upjohn Company LLC.