Allergic Conjunctivitis

• FDA approval · 2015-06-30
  FDA Approved: PATADAY TWICE A DAY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application for Pataday Twice a Day Relief (olopatadine hydrochloride) by Alcon Laboratories, Inc.

• FDA approval · 2015-05-12
  FDA Approved: EYE ALLERGY RELIEF — Supplemental Application (DOLGENCORP, LLC)

  The FDA granted a supplemental approval for Eye Allergy Relief (pheniramine maleate and naphazoline hydrochloride) from DolGenCorp, LLC, und…

• FDA approval · 2015-04-13
  FDA Approved: CHILDRENS CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Children's Cetirizine Hydrochloride (cetirizine hydrochloride) from Sun Pharmaceutical Indus…

• FDA approval · 2015-02-11
  FDA Approved: EYE ITCH RELIEF — Supplemental Application (Target Corporation)

  The FDA approved a supplemental application for Eye Itch Relief (ketotifen fumarate) by Target Corporation. The product is an ophthalmic tre…

• FDA approval · 2015-01-30
  FDA Approved: PATADAY ONCE DAILY RELIEF — Original Application (Alcon Laboratories, Inc.)

  FDA approved Pataday Once Daily Relief (olopatadine hydrochloride) from Alcon Laboratories in an Original Application for the treatment of a…

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• FDA approval · 2014-12-04
  FDA Approved: LASTACAFT — Supplemental Application (Allergan, Inc.)

  FDA approves Allergan's supplemental application for LASTACAFT (alcaftadine), leading to changes in the product labeling.

• FDA approval · 2014-10-29
  FDA Approved: DYMISTA — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DYMISTA (azelastine hydrochloride and fluticasone propionate) from Viatris Specialty LLC, under …

• FDA approval · 2014-10-08
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Apotex Corp.)

  FDA approved a generic olopatadine hydrochloride product (Apotex Corp.) under an Original Application.

• FDA approval · 2014-07-25
  FDA Approved: LASTACAFT — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for Lastacaft (alcaftadine).

• FDA approval · 2014-06-23
  FDA Approved: NAPHCON A — Supplemental Application (Alcon Laboratories, Inc.)

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

• FDA approval · 2014-02-19
  FDA Approved: KETOTIFEN FUMARATE OPHTHALMIC SOLUTION — Supplemental Application (Sentiss Pharmaceuticals LLC)

  FDA approved a supplemental application for Ketotifen Fumarate Ophthalmic Solution from Sentiss Pharmaceuticals LLC.

• FDA approval · 2013-10-09
  FDA Approved: LOTEPREDNOL ETABONATE — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for Loteprednol etabonate (Lotemax) by Bausch & Lomb Americas Inc., approving changes to the product…

• FDA approval · 2013-09-12
  FDA Approved: PATADAY TWICE A DAY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application for Pataday Twice a Day Relief (olopatadine hydrochloride) from Alcon Laboratories, expanding labeli…

• FDA approval · 2013-04-04
  FDA Approved: CROMOLYN SODIUM — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's original ANDA for cromolyn sodium.

• FDA approval · 2013-03-13
  FDA Approved: AZELASTINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for azelastine hydrochloride from Apotex Corp., as indicated by the FDA's 'AP' submission status for…

• FDA approval · 2013-02-12
  FDA Approved: FML — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for FML (fluorometholone), resulting in updated labeling for the ophthalmic corticosteroid.

• FDA approval · 2012-12-18
  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 eye drop containing naphazoline hydrochlor…

• FDA approval · 2012-06-28
  FDA Approved: BEPOTASTINE BESILATE — Supplemental Application (Bausch & Lomb Americas Inc.)

  The FDA approved a supplemental application for Bepotastine besilate (Bausch & Lomb Americas Inc.). The action updates the labeling on an al…

• FDA approval · 2012-05-31
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved the original application for azelastine hydrochloride, a generic product from Sandoz Inc.

• FDA approval · 2011-10-31
  FDA Approved: EPINASTINE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  The FDA approved Somerset Therapeutics' epinastine hydrochloride as a generic product under an original ANDA for the treatment of allergic c…

• FDA approval · 2011-02-15
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride from Ohm Laboratories, enabling its cetirizine hydrochloride product to…

• FDA approval · 2010-12-08
  FDA Approved: PATADAY ONCE DAILY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application for Pataday Once Daily Relief (olopatadine hydrochloride) from Alcon Laboratories, Inc.

• FDA approval · 2010-09-27
  FDA Approved: NAPHAZOLINE HCI AND PHENIRAMINE MALEATE — Original Application (Altaire Pharmaceuticals Inc.)

  FDA approved Altaire Pharmaceuticals' combination eye drops containing naphazoline hydrochloride and pheniramine maleate under an Original A…

• FDA approval · 2010-07-28
  FDA Approved: LASTACAFT — Original Application (Allergan, Inc.)

  FDA approved LASTACAFT (alcaftadine) from Allergan in an original application. It is indicated for relief of ocular itching associated with …

• FDA approval · 2009-09-08
  FDA Approved: BEPOTASTINE BESILATE — Original Application (Bausch & Lomb Americas Inc.)

  FDA approved the original NDA for bepotastine besilate (Bausch & Lomb Americas Inc.), an ophthalmic antihistamine, for allergic conjunctivit…