Cytomegalovirus Retinitis

• FDA approval · 2024-03-01
  FDA Approved: FOSCARNET SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the original ANDA for Foscarnet sodium from Amneal Pharmaceuticals LLC.

• 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 · 2023-11-29
  FDA Approved: FOSCARNET SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original application for Foscarnet Sodium, a generic antiviral intended for CMV and acyclovir-resistant HSV infections.

• FDA approval · 2023-06-05
  FDA Approved: FOSCARNET SODIUM — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved the original application for Foscarnet Sodium (generic foscarnet) from Heritage Pharmaceuticals/Avet Pharmaceuticals, enabl…

• 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…

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• 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 · 2022-08-22
  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 · 2022-06-29
  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 · 2022-02-17
  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 · 2021-04-21
  FDA Approved: FOSCARNET SODIUM — Original Application (Gland Pharma Limited)

  FDA approved the original application for a generic foscarnet sodium product manufactured by Gland Pharma Limited.

• 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 · 2020-10-28
  FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)

  FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) submitted by Clinigen Limited.

• 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 · 2020-03-12
  FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for valganciclovir hydrochloride by NorthStar Rx LLC, enabling a generic valganciclovir product.

• FDA approval · 2020-03-12
  FDA Approved: VALGANCICLOVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for a generic valganciclovir product, authorizing Camber Pharmaceuticals to market valganciclovir fo…

• FDA approval · 2020-01-31
  FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for valganciclovir hydrochloride (generic valganciclovir) by Somerset Therapeutics, LLC.

• FDA approval · 2019-12-26
  FDA Approved: VALGANCICLOVIR — Original Application (Ajanta Pharma USA Inc.)

  FDA approved the original ANDA for valganciclovir from Ajanta Pharma USA Inc., establishing a generic antiviral product. It is indicated for…

• FDA approval · 2018-11-08
  FDA Approved: GANCICLOVIR — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved the original application for a generic version of ganciclovir (ganciclovir sodium) from Slate Run Pharmaceuticals, LLC.

• FDA approval · 2018-08-02
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

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

• FDA approval · 2018-08-02
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

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

• FDA approval · 2017-12-12
  FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approves valganciclovir hydrochloride as an original generic drug via ANDA 206876 from Dr. Reddy's Laboratories Inc.

• FDA approval · 2017-02-24
  FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)

  The FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) submitted by Clinigen Limited. The approval reflects an update r…

• FDA approval · 2016-12-06
  FDA Approved: GANCICLOVIR — Original Application (Endo USA, Inc.)

  FDA approves Endo USA's ganciclovir as a generic product under an Original Application, enabling marketing of a generic form of ganciclovir.

• FDA approval · 2016-11-10
  FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)

  The FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) submitted by Clinigen Limited.