Allergic Conjunctivitis

• FDA approval · 2026-01-30
  FDA Approved: CETIRIZINE HCL — Supplemental Application (AMERISOURCE BERGEN)

  The FDA approved a supplemental application for cetirizine hydrochloride, submitted by Amerisource Bergen.

• EMA approval · 2026-01-22
  EMA Authorised: Opatanol (olopatadine hydrochloride) — Novartis Europharm Limited

  EMA authorised Opatanol (olopatadine hydrochloride) for allergic conjunctivitis, with Novartis Europharm Limited as the marketing authorisat…

• FDA approval · 2026-01-06
  FDA Approved: EYE ALLERGY ITCH RELIEF — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original ANDA for Eye Allergy Itch Relief containing olopatadine hydrochloride ophthalmic solution, a generic version of an…

• FDA approval · 2025-09-23
  FDA Approved: FLAREX — Supplemental Application (Eyevance Pharmaceuticals)

  The FDA granted a supplemental approval for FLAREX (fluorometholone acetate) by Eyevance Pharmaceuticals. The notice indicates FDA approval …

• FDA approval · 2025-08-29
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride from Rising Pharma Holdings, Inc., indicating an update to the approved…

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• FDA approval · 2025-06-24
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for promethazine hydrochloride from Hikma Pharmaceuticals USA, confirming the approval of a generic …

• FDA approval · 2025-05-20
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved the original application for Loteprednol etabonate ophthalmic drops from Amneal Pharmaceuticals NY LLC, providing a generic…

• FDA approval · 2025-04-15
  FDA Approved: PATADAY TWICE A DAY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application to Pataday Twice a Day Relief (olopatadine hydrochloride) from Alcon Laboratories, expanding the pro…

• FDA approval · 2025-04-15
  FDA Approved: PATADAY ONCE DAILY RELIEF — Supplemental Application (Alcon Laboratories, Inc.)

  FDA approved a supplemental application for PATADAY ONCE DAILY RELIEF (olopatadine hydrochloride) from Alcon Laboratories, expanding the lab…

• FDA approval · 2025-04-15
  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.

• EMA approval · 2025-03-25
  EMA Authorised: Emadine (emedastine difumarate) — Immedica Pharma AB

  The European Medicines Agency authorised Emadine (emedastine difumarate) for allergic conjunctivitis, with Immedica Pharma AB as the marketi…

• FDA approval · 2025-02-28
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (GLENMARK THERAPEUTICS INC., USA)

  The FDA approved Glenmark Therapeutics' olopatadine hydrochloride as an original ANDA, permitting the marketing of a generic product.

• FDA approval · 2024-12-18
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved Somerset Therapeutics' original application for olopatadine hydrochloride ophthalmic solution as a generic treatment for allerg…

• FDA approval · 2024-10-02
  FDA Approved: ALCAFTADINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved the original application for ALCAFTADINE (alcaftadine) by Alembic Pharmaceuticals as a generic ophthalmic solution for allergy-…

• FDA approval · 2024-08-14
  FDA Approved: BEPOTASTINE BESILATE — Original Application (Somerset Therapeutics, LLC)

  The FDA approved the original application for bepotastine besilate, a generic antihistamine for allergic conjunctivitis, submitted by Somers…

• FDA approval · 2024-08-07
  FDA Approved: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for olopatadine hydrochloride ophthalmic solution from Bausch & Lomb, indicating regulatory appr…

• FDA approval · 2024-07-10
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Padagis US LLC)

  FDA approves Padagis US LLC Loteprednol etabonate ophthalmic suspension under an original ANDA application.

• FDA approval · 2024-06-05
  FDA Approved: AZELASTINE HCL — Original Application (Amneal Pharmaceuticals NY LLC)

  ANDA approval for AZELASTINE HCL (azelastine) by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2024-04-24
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for Loteprednol etabonate, a generic ophthalmic corticosteroid for inflammatory eye…

• FDA approval · 2024-04-09
  FDA Approved: OLOPATADINE — Supplemental Application (Somerset Therapeutics, LLC)

  The FDA approved a supplemental application for olopatadine (ANDA206306) submitted by Somerset Therapeutics, LLC. The snippet indicates a su…

• FDA approval · 2024-03-01
  FDA Approved: ALCAFTADINE — Original Application (Gland Pharma Limited)

  FDA approves ALCAFTADINE under an Original Application (ANDA) from Gland Pharma Limited.

• FDA approval · 2024-01-09
  FDA Approved: FLUOROMETHOLONE OPHTHALMIC SUSPENSION — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC’s fluorometholone ophthalmic suspension under an Original Application (ANDA216348).

• FDA approval · 2023-06-23
  FDA Approved: ALCAFTADINE — Original Application (Aurohealth LLC)

  FDA approved the Original Application for ALCAFTADINE by Aurohealth LLC, establishing a generic version of the antihistamine eye drop. The a…

• FDA approval · 2023-06-07
  FDA Approved: RYALTRIS — Supplemental Application (HIKMA SPECIALTY USA INC.)

  FDA approved a supplemental application for RYALTRIS (olopatadine hydrochloride and mometasone furoate) submitted by Hikma Specialty USA Inc…

• FDA approval · 2023-04-12
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (ARMAS PHARMACEUTICALS INC.)

  FDA approved Loteprednol etabonate ophthalmic suspension from Armas Pharmaceuticals Inc. under an Original Application for use in ocular inf…