Open-angle Glaucoma

• FDA approval · 2014-12-19
  FDA Approved: BETAXOLOL — Supplemental Application (Epic Pharma LLC)

  The FDA approved a supplemental application (ANDA075541) for Betaxolol from Epic Pharma LLC, marking an approved change under the ANDA proce…

• FDA approval · 2014-09-29
  FDA Approved: LUMIGAN — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Lumigan (bimatoprost) submitted by Allergan, Inc.

• FDA approval · 2014-09-25
  FDA Approved: BETAXOLOL HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for betaxolol hydrochloride (Sandoz Inc). The action involves updating the product labeling.

• FDA approval · 2014-09-25
  FDA Approved: TIMOLOL GFS — Supplemental Application (Sandoz Inc)

  FDA approved the supplemental application for TIMOLOL GFS (timolol maleate) from Sandoz Inc.

• FDA approval · 2014-09-11
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC — Original Application (Florida Pharmaceutical Products, LLC)

  FDA approved an original ANDA for dorzolamide hydrochloride ophthalmic solution (generic) from Florida Pharmaceutical Products, LLC.

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• FDA approval · 2014-09-03
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE — Original Application (Indoco Remedies Limited)

  FDA approved Indoco Remedies Limited's generic dorzolamide hydrochloride-timolol maleate ophthalmic solution for lowering intraocular pressu…

• FDA approval · 2014-05-19
  FDA Approved: ALPHAGAN P — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Alphagan P (brimonidine tartrate) from Allergan, Inc.

• FDA approval · 2014-01-22
  FDA Approved: ALPHAGAN P — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental NDA for ALPHAGAN P (brimonidine tartrate) from Allergan, Inc.

• FDA approval · 2013-07-22
  FDA Approved: LUMIGAN — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Lumigan (bimatoprost) filed by Allergan, resulting in changes to labeling or indication.

• FDA approval · 2013-03-13
  FDA Approved: LATANOPROST — Supplemental Application (Mylan Pharmaceuticals Inc.)

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

• FDA approval · 2013-02-20
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for the Dorzolamide hydrochloride and timolol maleate eye drop by Bausch & Lomb Incorporated.

• FDA approval · 2012-03-13
  FDA Approved: LATANOPROST — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for latanoprost submitted by Mylan Pharmaceuticals Inc. The specific change to the product (e.g.…

• FDA approval · 2012-02-10
  FDA Approved: TAFLUPROST OPHTHALMIC — Original Application (Prasco Laboratories)

  FDA approves tafluprost ophthalmic solution under an original application for Prasco Laboratories.

• FDA approval · 2012-02-01
  FDA Approved: COSOPT PF — Original Application (Thea Pharma Inc.)

  FDA approved Cosopt PF (dorzolamide hydrochloride and timolol maleate) under an original application from Thea Pharma Inc. for reducing elev…

• FDA approval · 2011-09-30
  FDA Approved: TIMOPTIC IN OCUDOSE — Supplemental Application (Bausch & Lomb Incorporated)

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

• FDA approval · 2011-09-30
  FDA Approved: TIMOPTIC-XE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for TIMOPTIC-XE (timolol maleate) from Bausch & Lomb, reflecting an approved update to the product's…

• FDA approval · 2011-03-22
  FDA Approved: LATANOPROST — Original Application (Sandoz Inc)

  FDA approves the generic latanoprost (Sandoz) under Original Application (ANDA). The product is indicated for reduction of elevated intraocu…

• FDA approval · 2011-03-22
  FDA Approved: LATANOPROST — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for latanoprost from Somerset Therapeutics, enabling a generic latanoprost ophthalmic solution for red…

• FDA approval · 2011-03-08
  FDA Approved: BRINZOLAMIDE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for brinzolamide submitted by Sandoz Inc.

• FDA approval · 2011-01-28
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd.)

  FDA approved a supplemental application for dorzolamide hydrochloride from Advagen Pharma Ltd., a generic product used to treat open-angle g…

• FDA approval · 2010-08-31
  FDA Approved: LUMIGAN — Original Application (Allergan, Inc.)

  The FDA approved Lumigan (bimatoprost) from Allergan, Inc. as an original application for lowering intraocular pressure in adults with open-…

• FDA approval · 2010-08-31
  FDA Approved: LATANOPROST — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for latanoprost filed by Mylan Pharmaceuticals, approving a generic version of latanoprost for l…

• FDA approval · 2010-08-13
  FDA Approved: ALPHAGAN P — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Alphagan P (brimonidine tartrate) from Allergan, Inc., likely involving labeling changes or …

• FDA approval · 2010-08-03
  FDA Approved: BRIMONIDINE TARTRATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for brimonidine tartrate submitted by Sandoz Inc., representing a regulatory update to the product.

• FDA approval · 2010-07-29
  FDA Approved: LATANOPROST — Supplemental Application (Mylan Pharmaceuticals Inc.)

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