Cytomegalovirus Infections

• EMA approval · 2025-12-12
  EMA Authorised: Prevymis (Letermovir) — Merck Sharp & Dohme B.V.

  The EMA authorised Prevymis (letermovir) from Merck Sharp & Dohme B.V. for cytomegalovirus infections. It carries an orphan designation.

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

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

• FDA approval · 2016-03-31
  FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Original Application (NorthStar Rx LLC)

  FDA approved an original application for valganciclovir hydrochloride (generic) to be marketed by NorthStar Rx LLC.

• FDA approval · 2012-06-27
  FDA Approved: CIDOFOVIR — Original Application (Mylan Institutional LLC)

  FDA approved the original application for cidofovir anhydrous (CIDOFOVIR) from Mylan Institutional LLC, indicating a generic version of cido…

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