Cytomegalovirus Retinitis

• 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 · 2016-03-31
  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 · 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.

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• FDA approval · 2015-05-29
  FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)

  The FDA approves a supplemental application for FOSCAVIR (foscarnet sodium) filed by Clinigen Limited.

• 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 · 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 · 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…

• 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 · 2010-06-21
  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.

• FDA approval · 2009-09-15
  FDA Approved: ZIRGAN — Original Application (Bausch & Lomb Incorporated)

  FDA approved Zirgan (ganciclovir ophthalmic gel) under its original application by Bausch & Lomb for the treatment of cytomegalovirus retini…

• 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…