Allergic Conjunctivitis

• FDA approval · 2017-08-18
  FDA Approved: AZELASTINE — Original Application (Ascend Laboratories, LLC)

  The FDA approved the original application for azelastine, a generic antihistamine, submitted by Ascend Laboratories, LLC.

• FDA approval · 2017-07-26
  FDA Approved: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION — Original Application (Bausch & Lomb Incorporated)

  FDA approved an original Abbreviated New Drug Application for olopatadine hydrochloride ophthalmic solution by Bausch & Lomb for relief of i…

• EMA approval · 2017-07-21
  New medicine for rare form of eye allergy in children and teenagers

  EMA approves a new medicine for a rare form of eye allergy in children and teenagers, expanding treatment options for this condition.

• FDA approval · 2017-06-28
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (GLENMARK THERAPEUTICS INC., USA)

  FDA approves Glenmark's generic olopatadine hydrochloride ophthalmic solution for allergic conjunctivitis in an Original Application.

• FDA approval · 2017-05-30
  FDA Approved: ZERVIATE — Original Application (Harrow Eye, LLC)

  FDA approved ZERVIATE (cetirizine ophthalmic solution) via its original application by Harrow Eye, LLC for the treatment of allergic conjunc…

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• FDA approval · 2017-05-04
  FDA Approved: PRED FORTE — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Pred Forte (prednisolone acetate ophthalmic suspension) from Allergan, updating/expanding its la…

• FDA approval · 2017-01-31
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved OLOPATADINE HYDROCHLORIDE ophthalmic solution under an Original Application for allergic conjunctivitis. The applicant is Padag…

• FDA approval · 2017-01-06
  FDA Approved: VISINE ALLERGY EYE RELIEF MULTI-ACTION — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for Visine Allergy Eye Relief Multi-Action, a combination eye drop containing naphazoline hydroc…

• FDA approval · 2016-12-22
  FDA Approved: AZELASTINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for azelastine hydrochloride from Sun Pharmaceutical Industries, updating the approved generic p…

• FDA approval · 2016-11-08
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride from Sun Pharmaceutical Industries, Inc., under the existing ANDA.

• FDA approval · 2016-11-08
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for cetirizine hydrochloride by Padagis Israel Pharmaceuticals Ltd. The document indicates the actio…

• FDA approval · 2016-08-26
  FDA Approved: VISINE ALLERGY EYE RELIEF MULTI-ACTION — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for Visine Allergy Eye Relief Multi-Action, a combination of naphazoline hydrochloride and pheni…

• FDA approval · 2016-05-12
  FDA Approved: CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION — Supplemental Application (Neos Therapeutics, LP)

  FDA approved a supplemental application to authorize a new extended-release oral suspension formulation of carbinoxamine maleate by Neos The…

• FDA approval · 2016-03-14
  FDA Approved: EYE ALLERGY RELIEF — Supplemental Application (DOLGENCORP, LLC)

  FDA approved a supplemental application for Eye Allergy Relief (pheniramine maleate and naphazoline hydrochloride) from DolgenCorp, LLC unde…

• FDA approval · 2016-03-10
  FDA Approved: VISINE ALLERGY EYE RELIEF MULTI-ACTION — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Visine Allergy Eye Relief Multi-Action, a combination product containing naphazoline hydrochlori…

• FDA approval · 2016-02-05
  FDA Approved: BEPOTASTINE BESILATE — Supplemental Application (Bausch & Lomb Americas Inc.)

  The FDA approved a supplemental application for bepotastine besilate (an antihistamine eye drop) submitted by Bausch & Lomb Americas Inc.

• FDA approval · 2016-01-13
  FDA Approved: ALOCRIL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for ALOCRIL (nedocromil sodium) by Allergan, Inc. The action approves changes described in the suppl…

• FDA approval · 2015-12-18
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Harris Teeter)

  FDA approved the original application for olopatadine hydrochloride (ophthalmic) from Harris Teeter, marking the approval of a generic produ…

• FDA approval · 2015-12-07
  FDA Approved: OLOPATADINE — Original Application (Somerset Therapeutics, LLC)

  FDA approved an original ANDA for olopatadine from Somerset Therapeutics, LLC, authorizing a generic ophthalmic product.

• FDA approval · 2015-12-07
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s original application for olopatadine hydrochloride, a generic antihistamine eye drop for allergic conjunctiv…

• FDA approval · 2015-12-07
  FDA Approved: OLOPATADINE HCL — Original Application (Sola Pharmaceuticals)

  FDA approved the generic olopatadine HCl ophthalmic solution from Sola Pharmaceuticals through an Original Application. This approval provid…

• FDA approval · 2015-09-30
  FDA Approved: LASTACAFT — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for LASTACAFT (alcaftadine) submitted by Allergan, Inc.

• FDA approval · 2015-09-18
  FDA Approved: EYE ALLERGY RELIEF — Supplemental Application (DOLGENCORP, LLC)

  FDA approved a supplemental application for Eye Allergy Relief containing pheniramine maleate and naphazoline hydrochloride, filed by Dolgen…

• FDA approval · 2015-08-18
  FDA Approved: EPINASTINE HYDROCHLORIDE — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approved a supplemental application for epinastine hydrochloride (generic product) by Somerset Therapeutics, LLC.

• FDA approval · 2015-07-31
  FDA Approved: NAPHCON A — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application for NAPHCON A (naphazoline hydrochloride and pheniramine maleate) by Alcon Laboratories, Inc.