Glaucoma

• FDA approval · 2020-04-03
  FDA Approved: TIMOLOL MALEATE — Supplemental Application (Pacific Pharma, Inc.)

  The FDA approved a supplemental application for timolol maleate submitted by Pacific Pharma, Inc.

• FDA approval · 2020-02-19
  FDA Approved: LATANOPROST — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approved a supplemental application for latanoprost submitted by Somerset Therapeutics, LLC.

• FDA approval · 2020-02-19
  FDA Approved: LATANOPROST — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for latanoprost from Rising Pharma Holdings, Inc., indicating a supplemental approval for this gener…

• FDA approval · 2019-11-25
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approves Somerset Therapeutics, LLC original application for pilocarpine hydrochloride ophthalmic solution (generic).

• FDA approval · 2019-10-18
  FDA Approved: ACETAZOLAMIDE — Original Application (Eywa Pharma Inc)

  FDA approved acetazolamide from Eywa Pharma Inc under an original application (ANDA 211556), making a generic version of the drug available.

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• FDA approval · 2019-10-17
  FDA Approved: ACETAZOLAMIDE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' Original Application for acetazolamide, granting approval of a generic version.

• FDA approval · 2019-08-13
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for pilocarpine hydrochloride from Aurobindo Pharma Limited (ANDA 212377).

• 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 · 2019-08-05
  FDA Approved: OSMITROL — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for Osmitol (mannitol) from Baxter Healthcare Company, indicating an update to its labeling/indicati…

• 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 · 2019-03-11
  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 · 2018-11-15
  FDA Approved: OSMITROL — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for Osmitrol (mannitol) submitted by Baxter Healthcare Company.

• FDA approval · 2018-10-05
  FDA Approved: METHAZOLAMIDE — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's generic methazolamide (ANDA 207438) for the treatment of glaucoma.

• 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 · 2018-07-03
  FDA Approved: PHOSPHOLINE IODIDE — Supplemental Application (Fera Pharmaceuticals, LLC)

  FDA approved a supplemental application for Phospholine Iodide (echothiophate iodide ophthalmic solution) from Fera Pharmaceuticals, LLC.

• 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 · 2017-12-22
  FDA Approved: MITOSOL — Supplemental Application (Mobius Therapeutics LLC)

  The FDA approved a supplemental application for MITOSOL (mitomycin) from Mobius Therapeutics LLC.

• FDA approval · 2017-11-20
  FDA Approved: ACETAZOLAMIDE — Original Application (Strides Pharma Science Limited)

  FDA approved an original application for acetazolamide from Strides Pharma Science Limited, establishing a generic version of the drug. The …

• 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 · 2017-04-06
  FDA Approved: IOPIDINE 1% — Supplemental Application (Harrow Eye, LLC)

  The FDA approved a supplemental application for IOPIDINE 1% (APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION) by Harrow Eye, LLC.

• 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.

• FDA approval · 2017-04-06
  FDA Approved: TIMOPTIC IN OCUDOSE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for TIMOPTIC IN OCUDOSE (timolol maleate) submitted by Bausch & Lomb Incorporated.

• FDA approval · 2016-10-27
  FDA Approved: ACETAZOLAMIDE — Original Application (Chartwell RX, LLC)

  FDA approved an original application for acetazolamide from Chartwell RX, LLC.