Postoperative Ocular Inflammation

• FDA approval · 2024-12-13
  FDA Approved: DIFLUPREDNATE — Original Application (Caplin Steriles Limited)

  The FDA approved Caplin Steriles Limited's original application for difluprednate, a generic ophthalmic corticosteroid, for treating ocular …

• FDA approval · 2024-07-10
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Padagis US LLC)

  FDA approves Padagis US LLC Loteprednol etabonate ophthalmic suspension under an original ANDA application.

• FDA approval · 2024-04-24
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for Loteprednol etabonate, a generic ophthalmic corticosteroid for inflammatory eye…

• FDA approval · 2023-04-12
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (ARMAS PHARMACEUTICALS INC.)

  FDA approved Loteprednol etabonate ophthalmic suspension from Armas Pharmaceuticals Inc. under an Original Application for use in ocular inf…

• FDA approval · 2022-11-16
  FDA Approved: DIFLUPREDNATE OPHTHALMIC EMULSION — Original Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved Dr. Reddy's Difluprednate Ophthalmic Emulsion (0.05%) as an original application, providing a generic option for treating o…

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• FDA approval · 2021-12-10
  FDA Approved: MAXIDEX — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for MAXIDEX (dexamethasone) by Harrow Eye, LLC.

• FDA approval · 2021-11-17
  FDA Approved: DIFLUPREDNATE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved an original application for difluprednate ophthalmic (generic) manufactured by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2020-06-04
  FDA Approved: DEXYCU — Supplemental Application (EyePoint Pharmaceuticals US, Inc)

  FDA approved a supplemental application for DEXYCU (dexamethasone intraocular suspension) to expand its label for postoperative ocular infla…

• FDA approval · 2020-04-24
  FDA Approved: INVELTYS — Supplemental Application (ALCON LABORATORIES, INC.)

  The FDA approved a supplemental application for INVELTYS (loteprednol etabonate) from Alcon Laboratories, Inc. The action likely involves la…

• FDA approval · 2018-08-22
  FDA Approved: INVELTYS — Original Application (ALCON LABORATORIES, INC.)

  FDA approved INVELTYS (loteprednol etabonate) ophthalmic suspension 1% from Alcon Laboratories as an original application for the treatment …

• FDA approval · 2018-06-06
  FDA Approved: PRED MILD — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for PRED MILD (prednisolone acetate) by Allergan, Inc., adding a supplemental approval for this opht…

• FDA approval · 2018-06-06
  FDA Approved: PRED FORTE — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for PRED FORTE (prednisolone acetate ophthalmic suspension) submitted by Allergan, Inc.

• FDA approval · 2016-08-05
  FDA Approved: MAXIDEX — Supplemental Application (Harrow Eye, LLC)

  The FDA approved a supplemental application for MAXIDEX (dexamethasone) from Harrow Eye, LLC, authorizing changes to the drug's labeling as …

• FDA approval · 2016-03-10
  FDA Approved: MAXIDEX — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for MAXIDEX (dexamethasone) from Harrow Eye, LLC.

• FDA approval · 2015-12-02
  FDA Approved: BROMFENAC OPHTHALMIC SOLUTION — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for Bromfenac Ophthalmic Solution by Bausch & Lomb Americas, updating labeling to reflect postoperat…

• FDA approval · 2013-10-09
  FDA Approved: LOTEPREDNOL ETABONATE — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for Loteprednol etabonate (Lotemax) by Bausch & Lomb Americas Inc., approving changes to the product…

• FDA approval · 2012-11-27
  FDA Approved: DIFLUPREDNATE OPHTHALMIC — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for difluprednate ophthalmic from Sandoz Inc, authorizing changes to its labeling following submissi…

• FDA approval · 2008-06-23
  FDA Approved: DIFLUPREDNATE OPHTHALMIC — Original Application (Sandoz Inc)

  FDA approved the original application for difluprednate ophthalmic from Sandoz, a corticosteroid eye drop for ocular inflammation associated…