Cytomegalovirus Infection

• FDA approval · 2020-03-12
  FDA Approved: VALGANCICLOVIR — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for valganciclovir hydrochloride (generic product) from Strides Pharma Science Limited.

• 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…

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• FDA approval · 2019-12-20
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplementary application for PREVYMIS (letermovir) from Merck Sharp & Dohme LLC, updating the labeling.

• FDA approval · 2019-12-20
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2019-08-29
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Prevymis (letermovir) from Merck, expanding its approved use.

• FDA approval · 2019-03-05
  FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)

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

• 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 · 2017-12-08
  FDA Approved: GANCICLOVIR — Original Application (Pharmascience Inc.)

  FDA approved Pharmascience Inc.'s original ANDA for ganciclovir sodium, a generic version of ganciclovir. This approval makes a generic anti…

• FDA approval · 2017-11-08
  FDA Approved: PREVYMIS — Original Application (Merck Sharp & Dohme LLC)

  The FDA approved PREVYMIS (letermovir) in an original application for the prophylaxis of cytomegalovirus infection in CMV-seropositive adult…

• FDA approval · 2017-11-08
  FDA Approved: PREVYMIS — Original Application (Merck Sharp & Dohme LLC)

  The FDA approved PREVYMIS (letermovir) for prophylaxis of cytomegalovirus infection in CMV-seropositive adults receiving allogeneic hematopo…

• FDA approval · 2017-06-22
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

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

• 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 · 2016-07-18
  FDA Approved: VALGANCICLOVIR HYDROCHLORIDE FOR ORAL — Original Application (Actavis Pharma, Inc.)

  FDA approved an oral valganciclovir hydrochloride product from Actavis Pharma (Original Application) for prevention and treatment of cytomeg…

• FDA approval · 2016-04-28
  FDA Approved: VALGANCICLOVIR — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for valganciclovir hydrochloride (valganciclovir) by Strides Pharma Science Limited, a generic versi…

• FDA approval · 2016-03-18
  FDA Approved: VALGANCICLOVIR — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals’ original application for valganciclovir, enabling a generic version of the antiviral.

• FDA approval · 2015-07-14
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

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

• FDA approval · 2015-04-23
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

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

• FDA approval · 2015-04-23
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

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

• FDA approval · 2014-11-07
  FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)

  The FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) from Clinigen Limited, authorizing changes to the product labeli…