Glaucoma

• FDA approval · 2014-01-27
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for pilocarpine hydrochloride (Sandoz Inc) to update its labeling with additional indications.

• 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 · 2013-07-19
  FDA Approved: OSMITROL — Supplemental Application (Baxter Healthcare Company)

  The FDA approved a supplemental application for Osmitol (mannitol) from Baxter Healthcare Company, resulting in updated labeling to reflect …

• 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…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2013-02-07
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for pilocarpine hydrochloride submitted by Sandoz Inc, resulting in a labeling update for the produc…

• FDA approval · 2012-11-15
  FDA Approved: ISTALOL — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for ISTALOL (timolol maleate) from 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 · 2012-02-07
  FDA Approved: MITOSOL — Original Application (Mobius Therapeutics LLC)

  FDA approved MITOSOL (mitomycin C) from Mobius Therapeutics LLC under an original NDA. The approval introduces this ophthalmic formulation o…

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

  The FDA has approved a supplemental application for TIMOPTIC (timolol maleate) from Bausch & Lomb, indicating an approved change to the prod…

• FDA approval · 2011-07-14
  FDA Approved: ACETAZOLAMIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved the original ANDA for Acetazolamide from Westminster Pharmaceuticals, making a generic version of the carbonic anhydrase inhibi…

• FDA approval · 2011-03-22
  FDA Approved: LATANOPROST — Original Application (Bausch & Lomb Incorporated)

  FDA approved latanoprost as an original application generic product by Bausch & Lomb Incorporated.

• 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 · 2010-03-25
  FDA Approved: TIMOLOL MALEATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for timolol maleate, a generic drug by Rising Pharma Holdings, Inc.

• FDA approval · 2009-11-18
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE — Original Application (Sandoz Inc)

  The FDA approved a generic dorzolamide hydrochloride and timolol maleate ophthalmic solution from Sandoz for lowering intraocular pressure i…

• FDA approval · 2009-09-28
  FDA Approved: TIMOLOL MALEATE — Original Application (First Nation Group, LLC)

  The FDA approved First Nation Group, LLC's original application for timolol maleate, a generic ophthalmic beta-blocker used to lower intraoc…

• FDA approval · 2009-06-25
  FDA Approved: DORZOLAMIDE HCL — Original Application (Bausch & Lomb Incorporated)

  FDA approved the original ANDA for dorzolamide hydrochloride ophthalmic solution (Dorzolamide HCl) from Bausch & Lomb Incorporated, enabling…

• FDA approval · 2009-04-13
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's generic dorzolamide hydrochloride ophthalmic solution under an Original Application (ANDA). It is indicated for lo…

• FDA approval · 2008-12-10
  FDA Approved: ACETAZOLAMIDE — Original Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approves a generic acetazolamide product (Diamox) from XGen Pharmaceuticals DJB, Inc. under an Original Application.

• FDA approval · 2008-10-28
  FDA Approved: DORZOLAMIDE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd.)

  FDA approves Advagen Pharma Ltd.'s dorzolamide hydrochloride as a generic eye drop for lowering intraocular pressure in glaucoma and ocular …

• FDA approval · 2008-04-30
  FDA Approved: TIMOLOL MALEATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original ANDA for timolol maleate from Rising Pharma Holdings, Inc., confirming a generic timolol maleate product is author…