Herpes Simplex Virus Infection

• FDA approval · 2024-09-27
  FDA Approved: PENCICLOVIR — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original application (ANDA) for penciclovir topical cream (generic) from Padagis Israel Pharmaceuticals Ltd. for the treatm…

• FDA approval · 2024-01-08
  FDA Approved: ACYCLOVIR — Original Application (Slate Run Pharmaceuticals, LLC)

  The FDA approved the original ANDA for acyclovir from Slate Run Pharmaceuticals, LLC, authorizing a generic acyclovir product. This marks re…

• FDA approval · 2023-11-21
  FDA Approved: ACYCLOVIR — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved the original application for acyclovir by Alembic Pharmaceuticals Inc., making a generic version of the antiviral available.

• FDA approval · 2023-05-08
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for Valacyclovir hydrochloride from Aurobindo Pharma Limited. The approval confirms continued market…

• FDA approval · 2023-03-09
  FDA Approved: ACYCLOVIR SUSPENSION — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved ACYCLOVIR SUSPENSION under Original Application for a generic acyclovir suspension by Novadoz Pharmaceuticals LLC.

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• FDA approval · 2022-08-18
  FDA Approved: ACYCLOVIR — Original Application (Advagen Pharma Limited)

  FDA approves the original ANDA for acyclovir from Advagen Pharma Limited.

• FDA approval · 2022-07-01
  FDA Approved: ACYCLOVIR — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original ANDA for generic acyclovir, enabling brand-generic competition for this antiviral. The approva…

• FDA approval · 2022-05-03
  FDA Approved: DOCOSANOL — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the Original Application for docosanol from Alembic Pharmaceuticals Limited.

• FDA approval · 2021-11-15
  FDA Approved: ACYCLOVIR — Original Application (Solco Healthcare US, LLC)

  FDA approved the original application for acyclovir from Solco Healthcare US, LLC (oral generic).

• FDA approval · 2021-07-16
  FDA Approved: AVACLYR — Supplemental Application (Fera Pharmaceuticals, LLC)

  The FDA approved a supplemental application for AVACLYR (acyclovir) from Fera Pharmaceuticals, LLC.

• FDA approval · 2020-11-09
  FDA Approved: ACYCLOVIR — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's original application for acyclovir, a generic antiviral product for infections caused by herpes simplex virus and vari…

• FDA approval · 2020-01-29
  FDA Approved: ACYCLOVIR — Original Application (Xiromed, LLC)

  FDA approved the original ANDA for acyclovir from Xiromed, LLC, providing a generic version of the antiviral for herpes simplex virus infect…

• FDA approval · 2019-10-07
  FDA Approved: ACYCLOVIR — Original Application (Bionpharma Inc.)

  FDA approved the original ANDA for acyclovir by Bionpharma Inc., authorizing a generic version.

• FDA approval · 2019-03-29
  FDA Approved: AVACLYR — Original Application (Fera Pharmaceuticals, LLC)

  The FDA approves AVACLYR (acyclovir) from Fera Pharmaceuticals via an original NDA for treatment of herpes simplex and varicella-zoster viru…

• FDA approval · 2019-01-11
  FDA Approved: ACYCLOVIR — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's generic acyclovir tablets through an original ANDA.

• FDA approval · 2018-11-19
  FDA Approved: DOCOSANOL — Original Application (Care One (Retail Business Services, LLC.))

  FDA approved an original application for docosanol by Care One, establishing a generic docosanol topical product.

• FDA approval · 2018-08-31
  FDA Approved: ACYCLOVIR — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the original application for acyclovir from Zydus Pharmaceuticals (USA) Inc., enabling a generic version of acyclovir.

• FDA approval · 2016-04-14
  FDA Approved: XERESE — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for XERESE (acyclovir and hydrocortisone) from Bausch Health US LLC under NDA 022436. The approv…

• FDA approval · 2016-02-29
  FDA Approved: ACYCLOVIR — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc. for an original application of acyclovir as a generic product, expanding generic options for acy…

• 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…

• FDA approval · 2014-09-10
  FDA Approved: FAMCICLOVIR — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved a generic version of famciclovir under an original ANDA from Camber Pharmaceuticals, Inc.

• FDA approval · 2013-10-29
  FDA Approved: ACYCLOVIR — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original application for generic acyclovir, used to treat infections caused by herpes simplex virus and…

• FDA approval · 2013-10-11
  FDA Approved: ACYCLOVIR SODIUM — Original Application (Eugia US LLC)

  FDA approved the original application for acyclovir sodium by Eugia US LLC, a generic version of acyclovir.

• FDA approval · 2013-01-17
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for valacyclovir hydrochloride from Time Cap Laboratories, Inc.

• FDA approval · 2012-10-30
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a supplemental application for Valacyclovir hydrochloride submitted by Jubilant Cadista Pharmaceuticals Inc.