Varicose Veins

• FDA approval · 2025-01-30
  FDA Approved: ASCLERA — Supplemental Application (Methapharm, Inc)

  FDA approved a supplemental application for ASCLERA (polidocanol) submitted by Methapharm, Inc.

• FDA approval · 2019-12-09
  FDA Approved: SODIUM TETRADECYL SULFATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved an original ANDA for Sodium Tetradecyl Sulfate (Sodium tetradecyl sulfate) by Hikma Pharmaceuticals USA Inc., enabling its use …

• FDA approval · 2019-08-29
  FDA Approved: ASCLERA — Supplemental Application (Methapharm, Inc)

  FDA approved a supplemental application for ASCLERA (polidocanol) from Methapharm, Inc. The approval updates regulation around the product, …

• FDA approval · 2019-08-21
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  The FDA approved a supplemental application for VARITHENA (polidocanol) from Biocompatibles, Inc., updating the product labeling/indication.

• FDA approval · 2019-05-22
  FDA Approved: SOTRADECOL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for SOTRADECOL (sodium tetradecyl sulfate) submitted by Mylan Institutional LLC under an ANDA.

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• FDA approval · 2018-03-01
  FDA Approved: SOTRADECOL — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for SOTRADECOL (tetradecyl hydrogen sulfate ester) submitted by Mylan Institutional LLC under AN…

• FDA approval · 2017-12-21
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  The FDA approved a supplemental application for Varithena (polidocanol) submitted by Biocompatibles, Inc. The approval updates the product's…

• FDA approval · 2016-06-23
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  The FDA approved a supplemental application for Varithena (polidocanol) submitted by Biocompatibles, Inc., relating to its approved product …

• FDA approval · 2016-06-17
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  The FDA approved a supplemental application for Varithena (polidocanol) submitted by Biocompatibles, Inc. The entry notes the submission sta…

• FDA approval · 2016-04-18
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  The FDA approved a supplemental application for Varithena (polidocanol) from Biocompatibles, Inc.

• FDA approval · 2016-01-21
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  The FDA approved a supplemental application for Varithena (polidocanol) submitted by Biocompatibles, Inc.

• FDA approval · 2015-11-20
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  FDA approved a supplemental application for Varithena (polidocanol) by Biocompatibles, Inc., expanding the drug's labeling.

• FDA approval · 2015-06-02
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  FDA approved a supplemental application for Varithena (polidocanol) by Biocompatibles, Inc., signaling an update to its labeling or indicati…

• FDA approval · 2015-04-23
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  FDA approved a supplemental application for Varithena (polidocanol) from Biocompatibles, Inc., representing an additional regulatory action …

• FDA approval · 2015-01-20
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  The FDA approved a supplemental application for Varithena (polidocanol) from Biocompatibles, Inc., supporting an update to the product label…

• FDA approval · 2015-01-08
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  FDA approved a supplemental application for Varithena (polidocanol) from Biocompatibles, expanding its approved use for treatment of varicos…

• FDA approval · 2014-12-11
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  FDA approved a supplemental application for Varithena (polidocanol) submitted by Biocompatibles, Inc.

• FDA approval · 2014-09-16
  FDA Approved: VARITHENA — Supplemental Application (Biocompatibles, Inc.)

  The FDA approved a supplemental application for Varithena (polidocanol) from Biocompatibles, Inc. The action updates the product's labeling …

• FDA approval · 2013-11-25
  FDA Approved: VARITHENA — Original Application (Biocompatibles, Inc.)

  FDA approved Varithena (polidocanol) as an original application for the treatment of varicose veins of the leg due to incompetent great saph…

• FDA approval · 2010-03-30
  FDA Approved: ASCLERA — Original Application (Methapharm, Inc)

  FDA approves ASCLERA (polidocanol) for sclerotherapy to treat varicose veins and related superficial venous conditions.