Clostridioides Difficile Infection

• FDA approval · 2026-02-02
  FDA Approved: FIDAXOMICIN — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original ANDA for fidaxomicin (fidaxomicin) as a generic treatment for Clostridioides difficile infection.

• FDA approval · 2026-01-27
  FDA Approved: FIDAXOMICIN — Original Application (Torrent Pharmaceuticals Limited)

  The FDA approves the original application (ANDA) for fidaxomicin from Torrent Pharmaceuticals Limited, enabling the generic version to be ma…

• EMA approval · 2024-09-30
  EMA Authorised: Dificlir (fidaxomicin) — Tillotts Pharma GmbH

  The European Medicines Agency authorised Dificlir (fidaxomicin) for Clostridioides difficile infection, with Tillotts Pharma GmbH as the mar…

• FDA approval · 2024-01-16
  FDA Approved: FIDAXOMICIN — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva's generic fidaxomicin for the treatment of Clostridioides difficile infection under an ANDA approval.

• FDA approval · 2023-05-26
  FDA Approved: ZINPLAVA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ZINPLAVA (bezlotoxumab) from Merck Sharp & Dohme LLC.

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• FDA approval · 2022-11-14
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for vancomycin hydrochloride (generic) by Ascend Laboratories, LLC.

• FDA approval · 2022-02-16
  FDA Approved: VANCOMYCIN HYDROCHLORIDE FOR ORAL SOLUTION — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  FDA approved a supplemental application for vancomycin hydrochloride for oral solution, authorizing its oral formulation. The product is man…

• 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 · 2021-01-29
  FDA Approved: VANCOMYCIN HYDROCHLORIDE FOR ORAL SOLUTION — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  FDA approved a supplemental application to approve vancomycin hydrochloride for oral solution, expanding its use for treating Clostridioides…

• FDA approval · 2020-05-28
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for DIFICID (fidaxomicin) from Merck Sharp & Dohme LLC.

• FDA approval · 2020-01-24
  FDA Approved: DIFICID — Original Application (Merck Sharp & Dohme LLC)

  FDA approved DIFICID (fidaxomicin) under an original application from Merck Sharp & Dohme LLC for the treatment of Clostridioides difficile …

• FDA approval · 2020-01-24
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for DIFICID (fidaxomicin) from Merck Sharp & Dohme LLC, resulting in updated labeling under the supp…

• FDA approval · 2019-12-13
  FDA Approved: VANCOMYCIN HYDROCHLORIDE FOR ORAL SOLUTION — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  FDA approved a supplemental application for vancomycin hydrochloride for oral solution from Wilshire Pharmaceuticals, Inc. This approval aut…

• 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 · 2019-04-05
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for DIFICID (fidaxomicin) by Merck Sharp & Dohme LLC. The snippet does not specify the exact changes…

• FDA approval · 2019-03-15
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for DIFICID (fidaxomicin) by Merck Sharp & Dohme LLC.

• FDA approval · 2019-02-15
  FDA Approved: TYZAVAN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved TYZAVAN (vancomycin) from Hikma Pharmaceuticals USA Inc. under an Original Application (NDA211962). This marks the brand’s offi…

• FDA approval · 2018-04-03
  FDA Approved: FLAGYL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Flagyl (metronidazole) from Pfizer Laboratories Div Pfizer Inc, resulting in changes to the …

• FDA approval · 2018-01-26
  FDA Approved: VANCOMYCIN HYDROCHLORIDE FOR ORAL SOLUTION — Original Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved Wilshire Pharmaceuticals' vancomycin hydrochloride for oral solution under an original NDA for the treatment of Clostridioi…

• FDA approval · 2016-10-21
  FDA Approved: ZINPLAVA — Original Application (Merck Sharp & Dohme LLC)

  FDA approved ZINPLAVA (bezlotoxumab) from Merck Sharp & Dohme LLC under an original Biologics License Application. It is indicated to reduce…

• FDA approval · 2015-02-24
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for DIFICID (fidaxomicin) from Merck Sharp & Dohme LLC.

• FDA approval · 2013-11-18
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for DIFICID (fidaxomicin) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2013-06-06
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for DIFICID (fidaxomicin) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2013-04-04
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for DIFICID (fidaxomicin) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2013-02-21
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for DIFICID (fidaxomicin) submitted by Merck Sharp & Dohme LLC.