Meningitis

• EMA approval · 2026-08-18
  EMA Authorised: MenQuadfi (Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid) — Sanofi Winthrop Industrie

  EMA has authorised MenQuadfi, a meningococcal vaccine combination covering groups A, C, W-135, and Y (tetanus toxoid-conjugated), for mening…

• EMA approval · 2026-07-10
  EMA Authorised: Menveo (meningococcal group A, C, W-135 and Y conjugate vaccine) — GSK Vaccines S.r.l.

  The European Medicines Agency has authorised Menveo, a meningococcal group A, C, W-135 and Y conjugate vaccine by GSK Vaccines S.r.l., for i…

• 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…

• 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 · 2025-12-17
  EMA Authorised: Trumenba (Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B) — Pfizer Europe MA EEIG

  The EMA has authorised Trumenba, a vaccine against meningococcal disease caused by Neisseria meningitidis serogroup B, for use in Europe.

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• EMA approval · 2025-08-01
  EMA Authorised: Bexsero (outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254);recombinant Neisseria meningitidis group B fHbp fusion protein;recombinant Neisseria meningitidis group B NadA protein;recombinant Neisseria meningitidis group B NHBA fusion protein) — GSK Vaccines S.r.l.

  The European Medicines Agency authorised Bexsero, a meningococcal group B vaccine produced by GSK Vaccines S.r.l., for use in Europe. The va…

• EMA approval · 2025-02-13
  EMA Authorised: Nimenrix (Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid) — Pfizer Europe MA EEIG

  The EMA authorised Nimenrix, a quadrivalent meningococcal conjugate vaccine, for prevention of invasive meningococcal disease caused by sero…

• FDA approval · 2023-10-31
  FDA Approved: AMPICILLIN — Original Application (Aurobindo Pharma Limited)

  FDA approved an original application for Ampicillin from Aurobindo Pharma Limited, granting marketing authorization for a generic ampicillin…

• 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 · 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 · 2020-09-09
  FDA Approved: CEFTRIAXONE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application for Ceftriaxone and Dextrose from B. Braun Medical, resulting in an updated/expanded approval for th…

• FDA approval · 2019-08-16
  FDA Approved: MEROPENEM — Original Application (WG Critical Care, LLC)

  FDA approved WG Critical Care, LLC's original ANDA for Meropenem, providing a generic version of the carbapenem antibiotic.

• FDA approval · 2019-06-12
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved the vancomycin hydrochloride original application for Slate Run Pharmaceuticals, enabling a generic version of this antibiotic.

• FDA approval · 2018-07-10
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved an Original Application for vancomycin hydrochloride from Mylan Institutional LLC, confirming its use for treating serious infe…

• FDA approval · 2009-06-18
  FDA Approved: CEFTRIAXONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for ceftriaxone sodium (ceftriaxone) from Baxter Healthcare Company, authorizing changes to the appr…

• 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…