Glaucoma

• FDA approval · 2025-03-13
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for acetazolamide from ANI Pharmaceuticals, Inc., under ANDA 210588, indicating approval of a change…

• FDA approval · 2025-03-12
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for acetazolamide submitted by Ajanta Pharma USA Inc.

• FDA approval · 2025-02-11
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved a generic dorzolamide hydrochloride product under an Original Application by Somerset Therapeutics, LLC. Dorzolamide hydrochlor…

• FDA approval · 2025-01-27
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Acetazolamide from Accord Healthcare Inc. under an Abbreviated New Drug Application.

• FDA approval · 2025-01-24
  FDA Approved: ROCKLATAN — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application for ROCKLATAN (netarsudil and latanoprost ophthalmic solution) from Alcon Laboratories, Inc.

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• FDA approval · 2024-12-12
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetazolamide from Alembic Pharmaceuticals Inc., indicating a supplemental approval for this gen…

• FDA approval · 2024-11-26
  FDA Approved: ACETAZOLAMIDE EXTENDED-RELEASE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application from Micro Labs Limited for an extended-release formulation of acetazolamide.

• EMA approval · 2024-11-18
  EMA Authorised: Ganfort (bimatoprost;timolol) — AbbVie Deutschland GmbH & Co. KG

  The European Medicines Agency authorised Ganfort, a combination of bimatoprost and timolol, for glaucoma (open-angle) and ocular hypertensio…

• FDA approval · 2024-09-23
  FDA Approved: TRAVOPROST — Original Application (Somerset Therapeutics, LLC)

  FDA approved an Original Application for Travoprost from Somerset Therapeutics, LLC (ANDA 217228), indicating approval of a generic Travopro…

• FDA approval · 2024-09-16
  FDA Approved: IYUZEH — Supplemental Application (Thea Pharma Inc.)

  FDA approves a supplemental application for IYUZEH (latanoprost ophthalmic solution 0.005%). This approval expands the product's labeling re…

• FDA approval · 2024-09-16
  FDA Approved: TIMOLOL MALEATE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for TIMOLOL MALEATE (generic) by Somerset Therapeutics, LLC, for ophthalmic use to treat elevated intr…

• FDA approval · 2024-07-26
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetazolamide under ANDA 202693, submitted by Heritage Pharmaceuticals d/b/a Avet Pharmaceutical…

• FDA approval · 2024-07-25
  FDA Approved: ISTALOL — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for ISTALOL (timolol maleate) submitted by Bausch & Lomb Incorporated.

• FDA approval · 2024-07-12
  FDA Approved: TRAVOPROST OPHTHALMIC SOLUTION — Original Application (Gland Pharma Limited)

  FDA approved a generic travoprost ophthalmic solution (ANDA) from Gland Pharma Limited, expanding access to a prostaglandin analog for reduc…

• FDA approval · 2024-07-03
  FDA Approved: TIMOLOL HEMIHYDRATE — Original Application (Somerset Therapeutics, LLC)

  FDA approved a generic timolol hemihydrate eye drop for lowering intraocular pressure in adults with glaucoma or ocular hypertension.

• FDA approval · 2024-07-03
  FDA Approved: TIMOLOL MALEATE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for a generic timolol maleate product (ANDA) from Somerset Therapeutics, LLC, for lowering intraocular…

• FDA approval · 2024-05-28
  FDA Approved: TIMOLOL GFS — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for TIMOLOL GFS (timolol maleate) submitted by Sandoz Inc.

• FDA approval · 2024-05-15
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA has approved a supplemental application for acetazolamide submitted by Lifestar Pharma LLC.

• FDA approval · 2024-04-05
  FDA Approved: TAFLUPROST — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved Tafluprost as a generic product under an Original Application (ANDA) to Ingenus Pharmaceuticals, LLC.

• FDA approval · 2024-02-20
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE — Supplemental Application (Indoco Remedies Limited)

  FDA approved a supplemental application for a dorzolamide hydrochloride-timolol maleate eye drop manufactured by Indoco Remedies Limited.

• FDA approval · 2024-02-20
  FDA Approved: DORZOLAMIDE AND TIMOLOL — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for dorzolamide hydrochloride and timolol maleate ophthalmic solution from Leading Pharma, LLC.

• FDA approval · 2023-12-13
  FDA Approved: IDOSE TR — Original Application (Glaukos Corporation)

  The FDA approved IDOSE TR from Glaukos through an original NDA for travoprost delivered intracamerally to treat glaucoma by lowering intraoc…

• FDA approval · 2023-11-28
  FDA Approved: BIMATOPROST — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for bimatoprost filed by Alembic Pharmaceuticals Limited.

• FDA approval · 2023-11-22
  FDA Approved: BRIMONIDINE TARTRATE — Original Application (Micro Labs Limited)

  FDA approves the original application for brimonidine tartrate from Micro Labs Limited, adding a generic ophthalmic product for lowering int…

• FDA approval · 2023-08-25
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for acetazolamide sodium filed by Mylan Institutional LLC, approving the salt form of acetazolamide …