Allergic Rhinitis

• FDA approval · 2025-08-01
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for cetirizine hydrochloride from Sandoz Inc, granting regulatory clearance for this generic ant…

• CLINICAL_TRIALS research · 2025-07-31
  Clinical Trial Update: Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites

  Noninterventional study update assessing tolerability and safety of a single-strength updosing with Novo-Helisen Depot for house dust mite–r…

• FDA label_change · 2025-07-28
  FDA Approved: QUZYTTIR — Supplemental Application (TerSera Therapeutics LLC)

  FDA approves a supplemental application for QUZYTTIR (cetirizine hydrochloride) filed by TerSera Therapeutics, updating the product labeling…

• CLINICAL_TRIALS research · 2025-07-23
  Clinical Trial Update: Study of the Effects and Mechanisms of Yeast Postbiotics on Persistent Allergic Rhinitis Symptoms [NA]

  Clinical trial update investigating the effects and mechanisms of yeast-derived postbiotics on persistent allergic rhinitis symptoms, curren…

• FDA label_change · 2025-07-22
  FDA Approved: CHILDRENS XYZAL ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental labeling application for Children's XYZAL Allergy (levocetirizine dihydrochloride) by Chattem, Inc.

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• CLINICAL_TRIALS trial_result · 2025-07-18
  Clinical Trial Update: Urban Environmental Factors and Childhood Asthma

  A completed clinical trial sponsored by the National Institute of Allergy and Infectious Diseases evaluating the impact of urban environment…

• FDA approval · 2025-07-17
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride submitted by Rising Pharma Holdings, Inc. The approval relates to chang…

• CLINICAL_TRIALS trial_result · 2025-07-15
  Clinical Trial Update: Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction [Phase 2]

  Phase 2 trial evaluating grass pollen immunotherapy in combination with dupilumab for tolerance induction in grass pollen allergy-related al…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for levocetirizine dihydrochloride (generic) submitted by Chartwell RX, LLC.

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals Inc)

  FDA approved a supplemental application for Levocetirizine dihydrochloride from Marlex Pharmaceuticals Inc, granting regulatory authorizatio…

• FDA label_change · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's supplemental application for cetirizine hydrochloride, resulting in changes to the product labeling. C…

• FDA approval · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for cetirizine hydrochloride from Padagis Israel Pharmaceuticals Ltd, confirming approval under a su…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Glenmark, indicating an approved modification to an existing…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Dr.Reddy's laboratories Ltd.)

  The FDA approved a supplemental application for levocetirizine dihydrochloride from Dr. Reddy's Laboratories, indicating an FDA regulatory a…

• FDA approval · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for cetirizine hydrochloride from Amneal Pharmaceuticals LLC, authorizing modifications to the produ…

• FDA label_change · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for cetirizine hydrochloride, indicating a labeling or formulation-related update for the drug.

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Macleods Pharmaceuticals Limited.

• FDA approval · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE ORAL SOLUTION — Supplemental Application (APOZEAL PHARMACEUTICALS INC)

  FDA approved a supplemental application for cetirizine hydrochloride oral solution from Apozeal Pharmaceuticals Inc, expanding labeling for …

• FDA approval · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride, adding an oral solution dosage form for this generic product (Heritage…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Vensun Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Levocetirizine dihydrochloride from Vensun Pharmaceuticals, Inc., updating the approved product …

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's levocetirizine dihydrochloride under an ANDA. The notice indicates an approved supplement…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Padagis Israel Pharmaceuticals Ltd, indicating a regulatory …

• FDA approval · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride from Rising Pharma Holdings, Inc.

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application to market a generic levocetirizine dihydrochloride product. The product is…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for levocetirizine dihydrochloride, a generic antihistamine, under an ANDA.