Keratitis

• EMA approval · 2026-01-15
  EMA Authorised: Verkazia (ciclosporin) — Santen Oy

  EMA has authorised Verkazia (ciclosporin) from Santen Oy for the treatment of conjunctivitis and keratitis. The product has orphan medicinal…

• FDA approval · 2025-04-07
  FDA Approved: TOBRAMYCIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)

  Supplemental FDA approval for tobramycin and dexamethasone (Sandoz) as an ophthalmic combination product.

• EMA approval · 2024-10-25
  EMA Authorised: Oxervate (recombinant human nerve growth factor) — Dompe' Farmaceutici S.p.A.

  The EMA authorised Oxervate (cenegermin), a recombinant human nerve growth factor, for keratitis, with orphan designation and accelerated as…

• FDA approval · 2024-01-09
  FDA Approved: FLUOROMETHOLONE OPHTHALMIC SUSPENSION — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC’s fluorometholone ophthalmic suspension under an Original Application (ANDA216348).

• FDA approval · 2023-07-21
  FDA Approved: NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for Neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic suspension from Bausch & Lom…

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• FDA approval · 2021-05-14
  FDA Approved: MAXITROL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MAXITROL (neomycin sulfate, polymyxin B sulfate and dexamethasone), updating labeling for this o…

• FDA approval · 2019-04-19
  FDA Approved: TOBRAMYCIN OPHTHALMIC SOLUTION — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Tobramycin Ophthalmic Solution from Alembic Pharmaceuticals Inc. under an original generic application (ANDA).

• 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 · 2017-12-18
  FDA Approved: MAXITROL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MAXITROL (neomycin sulfate, polymyxin B sulfate and dexamethasone) from Novartis Pharmaceuticals…

• FDA approval · 2013-12-16
  FDA Approved: LOTEPREDNOL ETABONATE — Supplemental Application (Bausch & Lomb Americas Inc.)

  The FDA approved a supplemental application for Loteprednol Etabonate (Lotemax) from Bausch & Lomb Americas Inc.

• FDA approval · 2012-12-18
  FDA Approved: MAXITROL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for MAXITROL, a combination ophthalmic solution containing neomycin sulfate, polymyxin B sulfate…

• FDA approval · 2010-06-03
  FDA Approved: LOTEPREDNOL ETABONATE AND TOBRAMYCIN — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for Loteprednol etabonate and tobramycin, expanding labeling to treat inflammatory ocular conditions…

• FDA approval · 2009-03-20
  FDA Approved: DIFLUPREDNATE OPHTHALMIC — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for difluprednate ophthalmic, approving a generic corticosteroid ophthalmic solution for …

• FDA approval · 2009-02-13
  FDA Approved: TOBRADEX ST — Original Application (Harrow Eye, LLC)

  The FDA approved TOBRADEX ST (tobramycin/dexamethasone) from Harrow Eye, LLC via an original NDA for treating ocular infections and inflamma…

• FDA approval · 2008-09-15
  FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (Sandoz) to support a generic version of thi…