Ocular Hypertension

• FDA approval · 2024-08-09
  FDA Approved: BRIMONIDINE TARTRATE — Original Application (Somerset Therapeutics, LLC)

  The FDA approved the original application for Brimonidine Tartrate, a generic ophthalmic solution, enabling its sale for lowering intraocula…

• FDA approval · 2024-08-07
  FDA Approved: TRAVOPROST OPHTHALMIC SOLUTION, 0.004% — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Travoprost Ophthalmic Solution 0.004% from Mylan, establishing a generic version of travoprost f…

• FDA approval · 2024-08-07
  FDA Approved: TIMOLOL MALEATE — Original Application (Caplin Steriles Limited)

  FDA approved Caplin Steriles Limited's original ANDA for Timolol Maleate, a generic eye drop product.

• 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…

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• 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 · 2024-05-16
  FDA Approved: BRIMONIDINE TARTRATE/TIMOLOL MALEATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's generic fixed-dose combination eye drops containing brimonidine tartrate and timolol maleate for reducing intraocula…

• FDA approval · 2024-04-25
  FDA Approved: BRINZOLAMIDE — Supplemental Application (Oceanside Pharmaceuticals.)

  The FDA approved a supplemental application for Brinzolamide submitted by Oceanside Pharmaceuticals. The approval concerns the generic drug …

• 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 · 2024-03-29
  FDA Approved: TRAVOPROST OPHTHALMIC SOLUTION, 0.004% — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for travoprost ophthalmic solution 0.004% by Mylan Pharmaceuticals, expanding access to a generic pr…

• FDA approval · 2024-03-04
  FDA Approved: BRIMONIDINE — Original Application (Sandoz Inc)

  The FDA approved Sandoz's original ANDA for brimonidine tartrate ophthalmic solution, establishing a generic version of this glaucoma medica…

• 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 · 2024-02-20
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC — Supplemental Application (Florida Pharmaceutical Products, LLC)

  FDA approved a supplemental application for dorzolamide hydrochloride ophthalmic solution filed by Florida Pharmaceutical Products, LLC.

• FDA approval · 2024-02-13
  FDA Approved: BIMATOPROST — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for bimatoprost from Apotex Corp., authorizing a regulatory change under the ANDA framework.

• FDA approval · 2023-12-27
  FDA Approved: LATANOPROST — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for latanoprost filed by Bausch & Lomb Incorporated.

• 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 · 2023-10-10
  FDA Approved: LATANOPROST — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for latanoprost by Aurobindo Pharma Limited, approving a generic ophthalmic latanoprost product.…

• FDA approval · 2023-09-22
  FDA Approved: LATANOPROST — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for latanoprost from Rising Pharma Holdings, Inc., granting a new generic latanoprost product un…

• FDA approval · 2023-08-25
  FDA Approved: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for a fixed-dose combination eye drop containing brimonidine tartrate and timolol maleate, manufacture…

• FDA approval · 2023-08-14
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for dorzolamide hydrochloride and timolol maleate ophthalmic solution from Bausch & Lomb Incorporate…

• FDA approval · 2023-08-01
  FDA Approved: BRIMONIDINE TARTRATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved brimonidine tartrate for an original application (ANDA) from Alembic Pharmaceuticals Limited.