Ocular Inflammation
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-12-10FDA Approved: LOTEPREDNOL ETABONATE AND TOBRAMYCIN — Original Application (Alembic Pharmaceuticals Inc.)
FDA approves Alembic Pharmaceuticals' original ANDA for Loteprednol etabonate and tobramycin ophthalmic suspension, a combination eye drop f…
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FDA approval · 2025-09-23FDA Approved: FLAREX — Supplemental Application (Eyevance Pharmaceuticals)
The FDA granted a supplemental approval for FLAREX (fluorometholone acetate) by Eyevance Pharmaceuticals. The notice indicates FDA approval …
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FDA approval · 2025-05-20FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved the original application for Loteprednol etabonate ophthalmic drops from Amneal Pharmaceuticals NY LLC, providing a generic…
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FDA approval · 2025-03-20FDA Approved: DIFLUPREDNATE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approves Mylan's original generic application for difluprednate ophthalmic 0.05% (DIFLUPREDNATE) for reduction of ocular inflammation an…
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FDA approval · 2025-01-28FDA Approved: LOTEPREDNOL ETABONATE — Supplemental Application (ARMAS PHARMACEUTICALS INC.)
FDA approves a supplemental application for Loteprednol Etabonate from Armas Pharmaceuticals Inc. under ANDA 212080, finalizing the status o…
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FDA approval · 2024-12-13FDA 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 …
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FDA approval · 2024-12-13FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved Amneal Pharmaceuticals NY LLC's Loteprednol etabonate ophthalmic suspension as an original generic application (ANDA).
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FDA approval · 2024-07-10FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Padagis US LLC)
FDA approves Padagis US LLC Loteprednol etabonate ophthalmic suspension under an original ANDA application.
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FDA approval · 2024-04-24FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' original application for Loteprednol etabonate, a generic ophthalmic corticosteroid for inflammatory eye…
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FDA approval · 2023-04-12FDA 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…
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FDA approval · 2023-03-09FDA 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 …
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FDA approval · 2021-02-10FDA Approved: LOTEPREDNOL ETABONATE — Original Application (ARMAS PHARMACEUTICALS INC.)
FDA approved the original application for Loteprednol etabonate ophthalmic suspension from Armas Pharmaceuticals, establishing the generic c…
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FDA approval · 2020-10-26FDA Approved: EYSUVIS — Original Application (ALCON LABORATORIES, INC.)
FDA approved EYSUVIS (loteprednol etabonate) ophthalmic suspension from Alcon for short-term treatment of ocular inflammation after ocular s…
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FDA approval · 2020-03-02FDA 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…
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FDA approval · 2019-02-22FDA Approved: LOTEMAX SM — Original Application (Bausch & Lomb Incorporated)
The FDA approved LOTEMAX SM (loteprednol etabonate) ophthalmic gel under its original application (NDA 208219) from Bausch & Lomb. It is ind…
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FDA approval · 2018-06-06FDA Approved: PRED FORTE — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for PRED FORTE (prednisolone acetate ophthalmic suspension) submitted by Allergan, Inc.
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FDA approval · 2016-08-05FDA 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 …
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FDA approval · 2016-04-11FDA Approved: DIFLUPREDNATE OPHTHALMIC — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for difluprednate ophthalmic submitted by Sandoz Inc, resulting in updated labeling for the product.
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FDA approval · 2013-12-16FDA Approved: LOTEPREDNOL ETABONATE — Supplemental Application (Bausch & Lomb Americas Inc.)
The FDA approved a supplemental application for Loteprednol Etabonate (Lotemax) from Bausch & Lomb Americas Inc.
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FDA approval · 2013-04-05FDA 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…
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FDA approval · 2012-11-27FDA 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…
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FDA approval · 2012-10-02FDA Approved: LOTEPREDNOL ETABONATE AND TOBRAMYCIN — Supplemental Application (Bausch & Lomb Americas Inc.)
The FDA approved a supplemental application for the Loteprednol etabonate and tobramycin ophthalmic suspension by Bausch & Lomb Americas Inc…
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FDA approval · 2012-09-28FDA Approved: LOTEMAX — Original Application (Bausch & Lomb Incorporated)
FDA approved Lotemax (loteprednol etabonate) ophthalmic suspension under NDA 202872 for the treatment of postoperative ocular inflammation a…