Ocular Hypertension

• 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…

• 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.

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• FDA approval · 2020-11-23
  FDA Approved: COSOPT — Supplemental Application (Thea Pharma Inc.)

  The FDA approved a supplemental application for COSOPT, the dorzolamide hydrochloride and timolol maleate combination, submitted by Thea Pha…

• 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 · 2020-09-08
  FDA Approved: BIMATOPROST — Original Application (Micro Labs Limited)

  FDA approved the original application for BIMATOPROST from Micro Labs Limited, authorizing a generic version of bimatoprost for reducing int…

• 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 · 2020-09-01
  FDA Approved: LATANOPROST — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for LATANOPROST submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2020-08-12
  FDA Approved: BIMATOPROST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for bimatoprost submitted by Sandoz Inc, authorizing an addition/adjustment to the product's app…

• FDA approval · 2020-06-01
  FDA Approved: ROCKLATAN — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application for ROCKLATAN (netarsudil and latanoprost ophthalmic solution) submitted by Alcon Laboratories.

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

  FDA approved a supplemental application for timolol maleate from Pacific Pharma, Inc. under the ANDA. The action supplements the existing ap…

• 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 · 2020-03-25
  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 (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 · 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.