Cytomegalovirus Disease

• 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 · 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.

• EMA approval · 2017-11-10
  New medicine to prevent cytomegalovirus disease in stem cell transplant patients

  EMA announces a new medicine approved to prevent cytomegalovirus disease in stem cell transplant patients.

• FDA approval · 2013-03-28
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

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