Cytomegalovirus Infection

• FDA approval · 2014-11-04
  FDA Approved: VALGANCICLOVIR — Original Application (Strides Pharma Science Limited)

  The FDA approved Strides Pharma Science Limited's original application for valganciclovir hydrochloride as a generic drug (Valganciclovir).

• 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.

• FDA approval · 2012-02-10
  FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)

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

• FDA approval · 2010-08-05
  FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)

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

• FDA approval · 2010-06-21
  FDA Approved: GANCICLOVIR — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's original application for GANCICLOVIR SODIUM (ganciclovir), marking a generic approval.

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• FDA approval · 2009-08-28
  FDA Approved: VALCYTE — Original Application (H2-Pharma, LLC)

  FDA approved VALCYTE (valganciclovir hydrochloride) under the original application for cytomegalovirus infections, including CMV retinitis i…

• FDA approval · 2009-02-26
  FDA Approved: GANCICLOVIR — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ganciclovir sodium (generic ganciclovir) submitted by Hikma Pharmaceuticals USA Inc., under ANDA…

• FDA approval · 2007-11-27
  FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)

  FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) submitted by Clinigen Limited, updating the drug's approval status.