Ocular Hypertension

• 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: OMLONTI — Supplemental Application (Ocuvex Therapeutics, Inc.)

  The FDA approved a supplemental application for OMLONTI (omidenepag isopropyl) from Ocuvex Therapeutics, expanding the approved use of the o…

• 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 · 2022-09-19
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Original Application (Gland Pharma Limited)

  The FDA approved Gland Pharma Limited's generic dorzolamide hydrochloride and timolol maleate ophthalmic solution (ANDA 215520) for lowering…

• FDA approval · 2022-09-13
  FDA Approved: TIMOLOL MALEATE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals' original ANDA for Timolol Maleate ophthalmic solution, sanctioning a generic treatment option for open…

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• FDA approval · 2022-09-07
  FDA Approved: TIMOLOL MALEATE — Original Application (Micro Labs Limited)

  FDA approved timolol maleate from Micro Labs Limited under an original application (ANDA) for lowering intraocular pressure in open-angle gl…

• FDA approval · 2022-06-24
  FDA Approved: TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION — Original Application (FOSUN PHARMA USA INC)

  FDA approved TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION from Fosun Pharma USA Inc as an original ANDA product for lowering intraocular …

• FDA approval · 2022-04-20
  FDA Approved: BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — Original Application (Apotex Corp.)

  FDA approved Apotex's brimonidine tartrate/timolol maleate ophthalmic solution as an Original Application generic to lower intraocular press…

• FDA approval · 2022-04-04
  FDA Approved: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — Original Application (Sandoz Inc)

  FDA approves Sandoz Inc's original ANDA for a fixed-dose combination of brimonidine tartrate and timolol maleate to lower intraocular pressu…

• FDA approval · 2022-03-08
  FDA Approved: LUMIGAN — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Lumigan (bimatoprost) submitted by Allergan, Inc., resulting in an updated label for the pro…

• FDA approval · 2022-01-31
  FDA Approved: BRIMONIDINE TARTRATE — Original Application (Apotex Corp.)

  FDA approved the original application for brimonidine tartrate from Apotex Corp, a generic product used to lower intraocular pressure in gla…

• FDA approval · 2022-01-28
  FDA Approved: TAFLUPROST — Original Application (Sandoz Inc)

  FDA approves Sandoz's Tafluprost as an original application (ANDA) for generic tafluprost indicated to reduce intraocular pressure in open-a…

• FDA approval · 2022-01-27
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved the original generic application for dorzolamide hydrochloride from Sagent Pharmaceuticals. The topical solution is used to low…

• FDA approval · 2022-01-25
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Original Application (Micro Labs Limited)

  FDA approved the preservative-free fixed-dose combination of dorzolamide hydrochloride and timolol maleate under Micro Labs Limited's origin…

• FDA approval · 2021-12-13
  FDA Approved: TIMOPTIC IN OCUDOSE — Original Application (Nordic Pharma, Inc.)

  FDA approves Nordic Pharma's TIMOPTIC IN OCUDOSE (timolol maleate) under an original ANDA application.

• FDA approval · 2021-12-03
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd.)

  FDA approved a supplemental application for dorzolamide hydrochloride submitted by Advagen Pharma Ltd. The action reflects an approved suppl…

• FDA approval · 2021-11-17
  FDA Approved: TIMOPTIC — Supplemental Application (Bausch & Lomb Incorporated)

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

• FDA approval · 2021-09-23
  FDA Approved: BRIMONIDINE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's original application for Brimonidine, a generic ophthalmic solution, for lowering elevated…

• FDA approval · 2021-09-03
  FDA Approved: LATANOPROST — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for latanoprost by Bausch & Lomb Incorporated to update the product labeling.

• FDA approval · 2021-08-23
  FDA Approved: LATANOPROST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for LATANOPROST from Sandoz Inc., indicating an approved modification related to this generic produc…

• FDA approval · 2021-08-18
  FDA Approved: BRINZOLAMIDE — Original Application (Oceanside Pharmaceuticals.)

  FDA approved the original application for brinzolamide from Oceanside Pharmaceuticals, establishing a generic version of the ophthalmic drug…

• FDA approval · 2021-06-09
  FDA Approved: BETOPTIC S — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental NDA for BETOPTIC S (betaxolol hydrochloride) by Novartis Pharmaceuticals Corporation.

• FDA approval · 2021-05-21
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application from Micro Labs Limited for generic dorzolamide hydrochloride and timolol maleate ophthalmic solutio…

• FDA approval · 2021-05-14
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approves a supplemental application for the dorzolamide hydrochloride and timolol maleate combination eye drop, a generic product used t…

• FDA approval · 2021-05-14
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Original Application (Aurobindo Pharma Limited)

  FDA approved a new generic combination eye drop of dorzolamide hydrochloride and timolol maleate for lowering intraocular pressure in open-a…