Cytomegalovirus Infection

• EMA approval · 2025-10-22
  EMA Authorised: Livtencity (Maribavir) — Takeda Pharmaceuticals International AG Ireland Branch

  EU authorised Livtencity (maribavir) for cytomegalovirus infections, with orphan medicine designation.

• FDA approval · 2025-03-27
  FDA Approved: GANCICLOVIR — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Hikma's generic GANCICLOVIR SODIUM, confirming regulatory approval of this ganciclovir product.

• FDA approval · 2024-08-30
  FDA Approved: PREVYMIS — Original Application (Merck Sharp & Dohme LLC)

  FDA approved PREVYMIS (letermovir) from Merck for prophylaxis of cytomegalovirus infection in CMV-seropositive adults receiving an allogenei…

• FDA approval · 2024-08-30
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA granted approval of a supplemental application for PREVYMIS (Letermovir) from Merck Sharp & Dohme LLC.

• FDA approval · 2024-05-23
  FDA Approved: VALGANCICLOVIR — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for valganciclovir from Dr. Reddy's Laboratories Limited, supporting the continued approval of t…

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• FDA approval · 2024-03-22
  FDA Approved: LIVTENCITY — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIVTENCITY (maribavir) submitted by Takeda Pharmaceuticals America, expanding its labeling.

• FDA approval · 2024-02-15
  FDA Approved: GANCICLOVIR — Supplemental Application (Pharmascience Inc.)

  FDA approved Pharmascience Inc.'s supplemental application for ganciclovir sodium, allowing its continued marketing as a generic antiviral.

• FDA approval · 2023-08-02
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for PREVYMIS (letermovir) from Merck Sharp & Dohme LLC, expanding regulatory authorization.

• FDA approval · 2023-08-02
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Prevymis (letermovir) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2023-06-05
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for PREVYMIS (letermovir) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2023-04-26
  FDA Approved: LIVTENCITY — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIVTENCITY (maribavir) submitted by Takeda Pharmaceuticals America, Inc., resulting in an update…

• FDA approval · 2023-04-11
  FDA Approved: VALGANCICLOVIR — Original Application (Florida Pharmaceutical Products, LLC)

  FDA approved the original application for valganciclovir from Florida Pharmaceutical Products, LLC, authorizing the generic drug product for…

• FDA approval · 2023-01-20
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for PREVYMIS (letermovir) from Merck Sharp & Dohme LLC, updating the labeling as part of the sup…

• FDA approval · 2022-10-04
  FDA Approved: VALGANCICLOVIR — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic valganciclovir hydrochloride under an original ANDA (ANDA 211475), adding a generic option for …

• FDA approval · 2022-09-08
  FDA Approved: LIVTENCITY — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIVTENCITY (maribavir) filed by Takeda Pharmaceuticals America, Inc., indicating an approved…

• FDA approval · 2022-08-22
  FDA Approved: VALGANCICLOVIR — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for valganciclovir from Ajanta Pharma USA Inc., confirming regulatory approval of a generic valganci…

• FDA approval · 2022-08-18
  FDA Approved: VALGANCICLOVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for valganciclovir submitted by Camber Pharmaceuticals, Inc.

• FDA approval · 2022-06-29
  FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Supplemental Application (Somerset Therapeutics, LLC)

  The FDA approved a supplemental application to Somerset Therapeutics, LLC for valganciclovir hydrochloride (valganciclovir), authorizing a g…

• FDA approval · 2022-06-27
  FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for valganciclovir hydrochloride by NorthStar Rx LLC. This approval grants a generic formulation…

• FDA approval · 2022-02-17
  FDA Approved: VALGANCICLOVIR — Original Application (airis PHARMA PVT LTD)

  FDA approves the original application for valganciclovir from airis PHARMA PVT LTD, enabling a generic version of the antiviral for cytomega…

• FDA approval · 2022-01-18
  FDA Approved: LIVTENCITY — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIVTENCITY (maribavir) from Takeda Pharmaceuticals America, Inc., authorizing changes to the dru…

• FDA approval · 2020-11-24
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for VALCYTE (valganciclovir hydrochloride) submitted by H2-Pharma, LLC.

• FDA approval · 2020-06-08
  FDA Approved: GANCICLOVIR — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for GANCICLOVIR SODIUM from Fresenius Kabi USA, LLC. This action approves a generic version of g…

• FDA approval · 2020-06-08
  FDA Approved: GANCICLOVIR — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for ganciclovir from Endo USA, Inc., indicating an approved change to the product under the ANDA.

• FDA approval · 2020-03-23
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

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