Ocular Hypertension

• 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: BRIMONIDINE TARTRATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Brimonidine Tartrate filed by Sandoz Inc. The document does not specify the exact scope of t…

• 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 · 2014-09-19
  FDA Approved: LUMIGAN — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for LUMIGAN (bimatoprost).

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• 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.

• 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 · 2014-04-03
  FDA Approved: LATANOPROST — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental NDA for LATANOPROST submitted by Mylan Pharmaceuticals Inc. The approval pertains to latanoprost, a therapy used…

• FDA approval · 2014-03-12
  FDA Approved: ALPHAGAN P — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Alphagan P (brimonidine tartrate) from Allergan, indicating a modification or addition to th…

• 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 · 2013-08-28
  FDA Approved: TAFLUPROST OPHTHALMIC — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Tafluprost Ophthalmic submitted by Prasco Laboratories. Tafluprost ophthalmic is used to low…

• 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 · 2013-06-05
  FDA Approved: ALPHAGAN P — Supplemental Application (Allergan, Inc.)

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

• FDA approval · 2013-04-19
  FDA Approved: SIMBRINZA — Original Application (Alcon Laboratories, Inc.)

  The FDA approved SIMBRINZA (brinzolamide/brimonidine tartrate) through an original NDA by Alcon Laboratories, establishing it as a fixed-dos…

• 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 · 2013-02-27
  FDA Approved: LATANOPROST — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for latanoprost from Bausch & Lomb Incorporated, related to an existing latanoprost therapy.

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

  FDA approved a supplemental application for dorzolamide HCl (Bausch & Lomb Incorporated), updating the approval/labeling for this ophthalmic…

• 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 · 2012-10-11
  FDA Approved: COMBIGAN — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for COMBIGAN (brimonidine tartrate, timolol maleate) submitted by Allergan, Inc.

• FDA approval · 2012-03-15
  FDA Approved: LUMIGAN — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for LUMIGAN (bimatoprost) by Allergan, Inc.

• 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.