Idiopathic Urticaria

• CLINICAL_TRIALS trial_result · 2009-07-17
  Clinical Trial Update: Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria

  A completed clinical trial evaluating desloratadine in patients with allergic rhinitis or chronic idiopathic urticaria; results posted in 20…

• CLINICAL_TRIALS trial_result · 2009-07-09
  Clinical Trial Update: CUTE (Chronic Urticaria Treatment Evaluation) [Phase 4]

  Phase 4 trial update from UCB Pharma evaluating treatment for chronic idiopathic urticaria, with the study completed and results posted.

• FDA approval · 2009-04-27
  FDA Approved: CETIRIZINE HYDROCHLORIDE ORAL SOLUTION — Original Application (APOZEAL PHARMACEUTICALS INC)

  FDA approved Apozeal Pharmaceuticals' cetirizine hydrochloride oral solution as an original generic product.

• FDA approval · 2009-03-20
  FDA Approved: COUNTERACT ALLERGY — Supplemental Application (Melaleuca, Inc.)

  FDA approved a supplemental application for COUNTERACT ALLERGY (loratadine) from Melaleuca, Inc. This approval confirms the product as an ap…

• FDA label_change · 2009-03-20
  FDA Approved: LORATADINE ANTIHISTAMINE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approves a supplemental labeling application for loratadine antihistamine from Padagis Israel Pharmaceuticals Ltd, resulting in updated …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2009-01-29
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  FDA approved a supplemental application for Claritin RediTabs (loratadine) from Bayer Healthcare LLC.

• FDA approval · 2008-10-06
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Bionpharma Inc.)

  FDA approved Bionpharma Inc.'s original application for cetirizine hydrochloride, a generic antihistamine for allergic rhinitis and chronic …

• FDA approval · 2008-07-25
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) from Bayer HealthCare LLC to update the labeling.

• FDA approval · 2008-02-01
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) filed by Chattem, Inc., indicating an approved update…

• FDA approval · 2008-01-15
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved the original ANDA for cetirizine hydrochloride tablets from Dr. Reddy's Laboratories Limited, marking the approval of a generic…

• FDA approval · 2007-12-20
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental application for Claritin (loratadine) filed by Bayer HealthCare LLC.

• FDA approval · 2007-10-18
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) submitted by Chattem, Inc.

• FDA approval · 2007-09-19
  FDA Approved: GOOD NEIGHBOR PHARMACY CHILDRENS LORATADINE — Supplemental Application (AmerisourceBergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Children's Loratadine (loratadine) sponsored by AmerisourceBergen.

• FDA approval · 2007-05-25
  FDA Approved: XYZAL — Original Application (Chattem, Inc.)

  The FDA approved the original application for XYZAL (levocetirizine dihydrochloride) by Chattem, Inc., for the treatment of allergic rhiniti…

• FDA approval · 2007-04-11
  FDA Approved: ALLERGY RELIEF — Original Application (Ohm Laboratories Inc.)

  The FDA approved Ohm Laboratories Inc.'s original ANDA for ALLERGY RELIEF, a generic loratadine product. This marks approval of a generic an…

• FDA label_change · 2006-12-14
  FDA Approved: CLARINEX — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for CLARINEX (desloratadine) from Organon LLC. The approval updates the product labeling.

• FDA approval · 2006-07-07
  FDA Approved: CAREONE ALLERGY RELIEF — Supplemental Application (American Sales Company)

  FDA approves a supplemental application for CAREONE ALLERGY RELIEF (fexofenadine HCl) from American Sales Company.

• CLINICAL_TRIALS trial_result · 2006-06-30
  Clinical Trial Update: The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria [Phase 4]

  A Phase 4 clinical trial update evaluating the efficacy and safety of combining desloratadine with levocetirizine for chronic idiopathic urt…