Open-angle Glaucoma

• FDA approval · 2021-09-23
  FDA Approved: BRIMONIDINE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's original application for Brimonidine, a generic ophthalmic solution, for lowering elevated…

• FDA approval · 2021-09-03
  FDA Approved: LATANOPROST — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for latanoprost by Bausch & Lomb Incorporated to update the product labeling.

• FDA approval · 2021-08-18
  FDA Approved: BRINZOLAMIDE — Original Application (Oceanside Pharmaceuticals.)

  FDA approved the original application for brinzolamide from Oceanside Pharmaceuticals, establishing a generic version of the ophthalmic drug…

• FDA approval · 2021-05-14
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approves a supplemental application for the dorzolamide hydrochloride and timolol maleate combination eye drop, a generic product used t…

• FDA approval · 2021-05-04
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals' original application for a generic dorzolamide hydrochloride and timolol maleate ophthalmic solution u…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2021-03-19
  FDA Approved: TRAVOPROST OPHTHALMIC — Original Application (Micro Labs Limited)

  The FDA approved Micro Labs Limited's travoprost ophthalmic solution as an original application for reducing elevated intraocular pressure i…

• FDA approval · 2021-03-16
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for the fixed-dose combination dorzolamide hydrochloride and timolol maleate from Sandoz Inc.

• FDA approval · 2021-02-10
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE — Supplemental Application (Indoco Remedies Limited)

  FDA approved Indoco Remedies Limited's supplemental application for a generic dorzolamide hydrochloride and timolol maleate ophthalmic solut…

• FDA approval · 2020-12-21
  FDA Approved: XELPROS — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for XELPROS (latanoprost) by Sun Pharmaceutical Industries, expanding the product’s labeling.

• FDA approval · 2020-11-03
  FDA Approved: DURYSTA — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Durysta (bimatoprost) submitted by Allergan, Inc. This marks approval of an add-on to the ND…

• FDA approval · 2020-10-22
  FDA Approved: TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% — Original Application (Alembic Pharmaceuticals Inc.)

  Alembic Pharmaceuticals received FDA approval for timolol maleate ophthalmic gel-forming solution in 0.25% (and 0.5%) strengths via original…

• FDA approval · 2020-09-29
  FDA Approved: LUMIGAN — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for LUMIGAN (bimatoprost) from Allergan, Inc.

• FDA approval · 2020-09-03
  FDA Approved: TRAVOPROST — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application from Apotex Corp. for Travoprost (ophthalmic) under an ANDA, granting additional regulatory clearanc…

• FDA approval · 2020-05-28
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's generic dorzolamide hydrochloride and timolol maleate ophthalmic solution. It is indicated for reduction o…

• FDA approval · 2020-03-25
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for dorzolamide hydrochloride from Sandoz Inc., granting regulatory clearance for changes to thi…

• FDA approval · 2020-03-04
  FDA Approved: DURYSTA — Original Application (Allergan, Inc.)

  FDA approved DURYSTA (bimatoprost intracameral implant) from Allergan as the original approval for reducing intraocular pressure in adults w…

• FDA approval · 2020-02-19
  FDA Approved: LATANOPROST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for a generic latanoprost product from Sandoz Inc., enabling its market availability. The approv…

• FDA approval · 2020-01-27
  FDA Approved: TRAVOPROST — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application from Apotex Corp. for a generic travoprost product.

• FDA approval · 2020-01-21
  FDA Approved: BIMATOPROST — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for bimatoprost (generic) by Alembic Pharmaceuticals Limited.

• FDA approval · 2019-12-20
  FDA Approved: TRAVOPROST OPHTHALMIC SOLUTION USP, 0.004% TRAVOPROST — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' Travoprost ophthalmic solution 0.004% as a generic product under an Original Application.

• 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 · 2019-06-25
  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…

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

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