Glaucoma

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (TRUPHARMA, LLC)

  FDA approved a supplemental application for acetazolamide from TRUPHARMA, LLC under ANDA 211372. This action updates the approval status of …

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Eywa Pharma Inc)

  The FDA approved Eywa Pharma Inc's supplemental application for acetazolamide, enabling continued marketing of a generic acetazolamide produ…

• FDA approval · 2023-08-09
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' supplemental application for acetazolamide, finalizing approval for changes to the approved generic produc…

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

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

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• 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…

• FDA approval · 2023-05-24
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for acetazolamide submitted by Chartwell RX, LLC.

• FDA approval · 2023-05-19
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Acetazolamide from Accord Healthcare Inc., a generic drug.

• FDA approval · 2023-05-09
  FDA Approved: ACETAZOLAMIDE — Original Application (Marlex Pharmaceuticals, Inc.)

  FDA approved acetazolamide as an original ANDA from Marlex Pharmaceuticals, providing a generic version of the carbonic anhydrase inhibitor.…

• 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 · 2023-01-23
  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 · 2023-01-23
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetazolamide (generic) submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals In…

• 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 · 2022-12-12
  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 · 2022-11-28
  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 submitted by Sandoz Inc. This action supplements an existing approval for the op…

• FDA approval · 2022-10-18
  FDA Approved: METHAZOLAMIDE — Original Application (Precision Dose, Inc.)

  FDA approved Precision Dose, Inc.'s original application for methazolamide, a carbonic anhydrase inhibitor, as a new generic product for gla…

• 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…

• FDA approval · 2022-09-22
  FDA Approved: OMLONTI — Original Application (Ocuvex Therapeutics, Inc.)

  The FDA approved OMLONTI (omidenepag isopropyl) from Ocuvex Therapeutics as an Original Application (NDA 215092) for reducing intraocular pr…

• FDA approval · 2022-09-22
  FDA Approved: TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% — Original Application (NorthStar RxLLC)

  The FDA approved NorthStar RxLLC's timolol maleate ophthalmic gel forming solution 0.25% under an Original Application (ANDA) for open-angle…

• FDA approval · 2022-07-26
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for acetazolamide filed by Strides Pharma Science Limited, authorizing an update to the generic prod…