Ocular Hypertension

• FDA approval · 2023-07-28
  FDA Approved: BRINZOLAMIDE — Original Application (Padagis US LLC)

  FDA approved the original ANDA for brinzolamide from Padagis US LLC, authorizing a generic brinzolamide product.

• FDA approval · 2023-06-28
  FDA Approved: BRINZOLAMIDE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for brinzolamide from Sandoz Inc, signaling a regulatory update to the product.

• FDA approval · 2023-06-22
  FDA Approved: LEVOBUNOLOL HYDROCHLORIDE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for levobunolol hydrochloride (generic beta-blocker) from Bausch & Lomb Incorporated.

• FDA approval · 2023-06-02
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application to authorize a preservative-free version of dorzolamide hydrochloride and timolol maleate eye drops …

• FDA approval · 2023-05-26
  FDA Approved: TIMOLOL MALEATE — Original Application (Micro Labs Limited)

  The FDA approved Micro Labs Limited's original ANDA for Timolol Maleate Ophthalmic, a generic eye drop used to lower intraocular pressure in…

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• FDA approval · 2023-05-08
  FDA Approved: TIMOLOL MALEATE — Original Application (Armas Pharmaceuticals, Inc.)

  FDA approved TIMOLOL MALEATE as an Original Application (ANDA) for Armas Pharmaceuticals, a generic ophthalmic solution indicated to reduce …

• FDA approval · 2023-05-05
  FDA Approved: SIMBRINZA — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approves a supplemental application for Simbrinza (brinzolamide/brimonidine tartrate) from Alcon Laboratories, Inc.

• FDA approval · 2023-05-01
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals' original application for a dorzolamide hydrochloride and timolol maleate combination eye drop to reduc…

• FDA approval · 2023-04-26
  FDA Approved: LATANOPROST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for LATANOPROST from Sandoz Inc (AP), marking regulatory approval for this generic glaucoma therapy.

• FDA approval · 2023-03-29
  FDA Approved: BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.15% — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Brimonidine tartrate ophthalmic solution 0.15% from Alembic Pharmaceuticals as an Original Application (ANDA) for lowering intr…

• FDA approval · 2023-03-23
  FDA Approved: TIMOLOL MALEATE — Original Application (Aurobindo Pharma Limited)

  FDA approves original ANDA for timolol maleate ophthalmic solution from Aurobindo Pharma Limited, enabling a generic version for lowering in…

• FDA approval · 2023-01-23
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for dorzolamide hydrochloride (generic) submitted by Sandoz Inc to support its use as an ophthalmic …

• FDA approval · 2022-12-21
  FDA Approved: BRIMONIDINE TARTRATE — Original Application (Apotex Corp.)

  FDA approved the original application for Brimonidine Tartrate by Apotex Corp., adding a generic option for treating glaucoma and ocular hyp…

• FDA approval · 2022-12-20
  FDA Approved: BIMATOPROST — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA has approved a supplemental application for BIMATOPROST from Alembic Pharmaceuticals Inc., representing a supplemental approval for the …

• FDA approval · 2022-12-19
  FDA Approved: LATANOPROST — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for latanoprost filed by Mylan Pharmaceuticals Inc.

• FDA approval · 2022-12-13
  FDA Approved: IYUZEH — Original Application (Thea Pharma Inc.)

  FDA approved IYUZEH, latanoprost ophthalmic solution 0.005%, under an original NDA from Thea Pharma Inc. for reducing intraocular pressure i…

• FDA approval · 2022-12-12
  FDA Approved: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approves Upsher-Smith's original application for a generic fixed-dose combination of brimonidine tartrate and timolol maleate ophthalmic…

• FDA approval · 2022-12-05
  FDA Approved: LATANOPROST — Supplemental Application (Somerset Therapeutics, LLC)

  The FDA approved a supplemental application for latanoprost from Somerset Therapeutics, LLC. Latanoprost is used to lower intraocular pressu…

• FDA approval · 2022-12-01
  FDA Approved: BIMATOPROST — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Bimatoprost from Apotex Corp. under an Abbreviated New Drug Application (ANDA). The approval con…

• FDA approval · 2022-11-28
  FDA Approved: LATANOPROST — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for latanoprost from Rising Pharma Holdings, Inc.

• FDA approval · 2022-11-22
  FDA Approved: TIMOLOL MALEATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for timolol maleate from Sandoz Inc, supporting an additional generic ophthalmic product. Timolol ma…

• FDA approval · 2022-11-22
  FDA Approved: TIMOLOL MALEATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for timolol maleate submitted by Sandoz Inc. This action supplements an existing approval for the op…

• FDA approval · 2022-11-08
  FDA Approved: BIMATOPROST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for bimatoprost from Sandoz Inc.

• FDA approval · 2022-10-06
  FDA Approved: BIMATOPROST — Original Application (Aurobindo Pharma Limited)

  The FDA approved the Original Application for BIMATOPROST (bimatoprost) by Aurobindo Pharma Limited under ANDA205537.

• FDA approval · 2022-10-04
  FDA Approved: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — Original Application (Florida Pharmaceutical Products, LLC)

  FDA approved a generic combination product of brimonidine tartrate and timolol maleate for lowering intraocular pressure in glaucoma or ocul…