Ocular Hypertension

• FDA approval · 2019-11-08
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION — Original Application (Micro Labs Limited)

  FDA approved a generic dorzolamide hydrochloride ophthalmic solution from Micro Labs Limited as an original application to lower intraocular…

• FDA approval · 2019-09-03
  FDA Approved: LATANOPROST — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for LATANOPROST (latanoprost) from Aurobindo Pharma Limited, establishing a generic version of latanop…

• FDA approval · 2019-08-19
  FDA Approved: TAFLUPROST — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's tafluprost ophthalmic solution as an Original Application (generic) product.

• FDA approval · 2019-08-09
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals Inc.'s original application for Dorzolamide Hydrochloride as a generic drug. It is used to lower intrao…

• FDA approval · 2019-06-25
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Original Application (Somerset Therapeutics, LLC)

  FDA approved a generic dorzolamide hydrochloride and timolol maleate ophthalmic solution for lowering intraocular pressure in open-angle gla…

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• FDA approval · 2019-06-19
  FDA Approved: BIMATOPROST — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for BIMATOPROST from Somerset Therapeutics, LLC.

• FDA approval · 2019-06-13
  FDA Approved: DORZOLAMIDE AND TIMOLOL — Original Application (Leading Pharma, LLC)

  FDA approved Leading Pharma, LLC's dorzolamide hydrochloride and timolol maleate ophthalmic solution as an original application (ANDA 205295…

• FDA approval · 2019-05-02
  FDA Approved: TIMOLOL MALEATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings' original ANDA for timolol maleate, a generic ophthalmic beta-blocker intended to reduce intraocular pre…

• FDA approval · 2019-04-12
  FDA Approved: BIMATOPROST — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved the original application for bimatoprost from Alembic Pharmaceuticals Inc., authorizing a generic version of the glaucoma medic…

• FDA approval · 2019-03-22
  FDA Approved: BIMATOPROST — Original Application (Fosun Pharma USA Inc.)

  The FDA approved the original application for bimatoprost, a generic ophthalmic solution manufactured by Fosun Pharma USA Inc., expanding ac…

• FDA approval · 2019-03-12
  FDA Approved: ROCKLATAN — Original Application (Alcon Laboratories, Inc.)

  The FDA approved ROCKLATAN as an original application for a fixed-dose combination ophthalmic solution of netarsudil 0.02% and latanoprost 0…

• FDA approval · 2019-03-11
  FDA Approved: BRIMONIDINE TARTRATE — Original Application (Somerset Therapeutics, LLC)

  FDA approved a generic Brimonidine tartrate ophthalmic product (Original Application) from Somerset Therapeutics, LLC to treat open-angle gl…

• FDA approval · 2019-01-24
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Original Application (Leading Pharma, LLC)

  FDA approves the original application for dorzolamide hydrochloride as a generic ophthalmic medication indicated for open-angle glaucoma and…

• FDA approval · 2018-11-20
  FDA Approved: BIMATOPROST — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for bimatoprost from Apotex Corp.

• FDA approval · 2018-09-12
  FDA Approved: XELPROS — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves XELPROS (latanoprost) from Sun Pharmaceutical as a new ophthalmic solution for lowering intraocular pressure in open-angle glau…

• FDA approval · 2018-07-24
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE — Original Application (Aurobindo Pharma Limited)

  FDA approved a preservative-free fixed-dose combination eye drop containing dorzolamide hydrochloride and timolol maleate as a generic produ…

• FDA approval · 2018-07-16
  FDA Approved: TIMOPTIC-XE — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for TIMOPTIC-XE (timolol maleate) from Bausch & Lomb Incorporated, authorizing changes to the pr…

• FDA approval · 2018-06-11
  FDA Approved: VYZULTA — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for VYZULTA (latanoprostene bunod) submitted by Bausch & Lomb Incorporated.

• FDA approval · 2018-03-01
  FDA Approved: IOPIDINE 1% — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for IOPIDINE 1% (apraclidine hydrochloride ophthalmic solution) from Harrow Eye, LLC.

• FDA approval · 2018-03-01
  FDA Approved: APRACLONIDINE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for APRACLONIDINE submitted by Sandoz Inc.

• FDA approval · 2017-12-18
  FDA Approved: RHOPRESSA — Original Application (Alcon Laboratories, Inc.)

  FDA approved Rhopressa (netarsudil) from Alcon as an original NDA, indicated to reduce elevated intraocular pressure in adults with open-ang…

• FDA approval · 2017-11-02
  FDA Approved: VYZULTA — Original Application (Bausch & Lomb Incorporated)

  FDA approved VYZULTA (latanoprostene bunod), from Bausch & Lomb, as a new treatment for open-angle glaucoma and ocular hypertension.

• FDA approval · 2017-07-29
  FDA Approved: LUMIGAN — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Lumigan (bimatoprost) from Allergan, Inc. The action updates the product through labeling change…

• FDA approval · 2017-07-07
  FDA Approved: TRAVOPROST OPHTHALMIC SOLUTION, 0.004% — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves Mylan's travoprost ophthalmic solution 0.004% through an original application for lowering intraocular pressure in open-angle g…

• FDA approval · 2017-04-06
  FDA Approved: APRACLONIDINE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for apraclonidine filed by Sandoz Inc to modify/expand the drug's labeling or use.