Postoperative Ocular Pain

• FDA approval · 2025-02-18
  FDA Approved: BROMFENAC OPHTHALMIC SOLUTION — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental NDA for Bromfenac Ophthalmic Solution (bromfenac sodium) from Bausch & Lomb Americas Inc. to support use for pos…

• 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 · 2024-07-08
  FDA Approved: BROMFENAC OPHTHALMIC SOLUTION, 0.07% — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s generic bromfenac ophthalmic solution 0.07% under an Original Application for relief of ocular pain and redu…

• FDA approval · 2023-03-09
  FDA Approved: BROMSITE 0.075% — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for BromSite 0.075% (bromfenac) from Sun Pharmaceutical Industries, likely updating labeling or …

• 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 · 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 · 2020-03-02
  FDA Approved: DEXTENZA — Supplemental Application (Ocular Therapeutix, Inc.)

  FDA approved a supplemental application for DEXTENZA (dexamethasone) submitted by Ocular Therapeutix, Inc., related to its labeling for ocul…

• FDA approval · 2019-06-21
  FDA Approved: BROMFENAC OPHTHALMIC SOLUTION 0.09% — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Bromfenac Ophthalmic Solution 0.09% as an Original Application (ANDA) for ophthalmic use, marking a generic version of bromfena…

• 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 · 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 · 2015-07-01
  FDA Approved: BROMFENAC OPHTHALMIC SOLUTION — Supplemental Application (Bausch & Lomb Americas Inc.)

  The FDA approved a supplemental application for Bromfenac Ophthalmic Solution (bromfenac sodium) from Bausch & Lomb Americas, expanding its …

• FDA approval · 2014-07-03
  FDA Approved: ILEVRO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for ILEVRO (nepafenac) from Novartis Pharmaceuticals, expanding the labeling.

• FDA approval · 2013-04-05
  FDA Approved: BROMFENAC OPHTHALMIC SOLUTION — Original Application (Bausch & Lomb Americas Inc.)

  FDA approved Bromfenac ophthalmic solution (bromfenac sodium) from Bausch & Lomb Americas Inc. as an original NDA. It is indicated for relie…

• FDA approval · 2011-06-27
  FDA Approved: NEVANAC — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental NDA for NEVANAC (nepafenac) submitted by Harrow Eye, LLC.

• FDA approval · 2009-07-22
  FDA Approved: ACUVAIL — Original Application (Allergan, Inc.)

  ACUVAIL, an ophthalmic ketorolac tromethamine solution, received FDA approval for the management of pain associated with ocular surgery. The…

• FDA approval · 2008-05-08
  FDA Approved: NEVANAC — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for NEVANAC (nepafenac) from Harrow Eye, LLC.