Allergic Rhinitis

• FDA approval · 2020-06-16
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, — Original Application (Eywa Pharma Inc)

  FDA approved Eywa Pharma Inc for the original application of a generic brompheniramine maleate and pseudoephedrine hydrochloride combination…

• FDA approval · 2020-06-01
  FDA Approved: KETOTIFEN FUMARATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for ketotifen fumarate as a generic antihistamine product. This mark…

• CLINICAL_TRIALS trial_result · 2020-05-28
  Clinical Trial Update: Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy [Phase 2]

  Phase 2 clinical trial evaluating dupilumab as an adjunct to subcutaneous grass immunotherapy for allergic rhinitis completed with results p…

• FDA approval · 2020-05-08
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for azelastine hydrochloride from Aurobindo Pharma Limited.

• FDA approval · 2020-04-29
  FDA Approved: CURIST ALLERGY RELIEF — Original Application (Little Pharma, Inc.)

  FDA approved Little Pharma, Inc.'s CURIST ALLERGY RELIEF as the original ANDA for levocetirizine dihydrochloride 5 mg, a generic tablet for …

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• FDA approval · 2020-04-17
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved the original application for a generic combination cough/cold medicine containing brompheniramine maleate, pseudoephedrine hydr…

• FDA approval · 2020-03-17
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for Diphenhydramine hydrochloride from PAI Pharma, indicating an approved modification to an existin…

• FDA approval · 2020-03-05
  FDA Approved: LORATADINE — Supplemental Application (Wal-Mart Stores, Inc)

  FDA approved a supplemental application for loratadine submitted by Wal-Mart Stores, Inc., updating an already approved product under ANDA21…

• FDA approval · 2020-03-03
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for Allergy Relief (loratadine) from Ohm Laboratories Inc.

• FDA approval · 2020-03-03
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for cetirizine hydrochloride from Padagis Israel Pharmaceuticals Ltd. It is a generic antihistamine …

• FDA approval · 2020-03-03
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for cetirizine hydrochloride by Bionpharma Inc., under ANDA078488, granting regulatory approval …

• FDA label_change · 2020-03-03
  FDA Approved: CHILDREN ALLERGY — Supplemental Application (Walgreens)

  FDA approved a supplemental application for a pediatric allergy indication using fexofenadine hydrochloride (Children's Allergy), expanding …

• FDA label_change · 2020-03-03
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for cetirizine hydrochloride from Sun Pharmaceutical to update labeling under an ANDA.

• FDA approval · 2020-02-18
  FDA Approved: MONTELUKAST SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for Montelukast Sodium, a generic montelukast product.

• CLINICAL_TRIALS trial_result · 2020-01-03
  Clinical Trial Update: Role of Montelukast in Asthma and Allergic Rhinitis Patients [Phase 4]

  Phase 4 clinical trial update evaluating montelukast in patients with asthma and allergic rhinitis has completed.

• FDA approval · 2019-12-31
  FDA Approved: GOOD SENSE LEVOCETIRIZINE — Supplemental Application (L. Perrigo Company)

  FDA approved a supplemental application for Good Sense Levocetirizine (levocetirizine dihydrochloride) from L. Perrigo Company.

• FDA approval · 2019-12-23
  FDA Approved: LORATADINE — Original Application (GRANULES USA, INC.)

  FDA approved Granules USA, Inc.'s loratadine Original Application, granting a generic loratadine tablet product.

• CLINICAL_TRIALS trial_result · 2019-12-20
  Clinical Trial Update: A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure [Phase 4]

  Phase 4 trial evaluating changes in nasal airflow after allergen exposure for loratadine/pseudoephedrine tablet and fluticasone propionate n…

• FDA approval · 2019-12-13
  FDA Approved: CETIRIZINE HCL — Supplemental Application (AMERISOURCE BERGEN)

  FDA approved a supplemental application for Cetirizine HCl submitted by AmerisourceBergen, updating the NDA to reflect the approved suppleme…

• FDA approval · 2019-12-06
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for montelukast sodium (generic montelukast).

• CLINICAL_TRIALS trial_result · 2019-12-05
  Clinical Trial Update: Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing IL-5 in Children With Allergic Rhinitis [Phase 4]

  Phase 4 trial update evaluating nebulized resveratrol with carboxymethyl-β-glucan to reduce IL-5 in children with allergic rhinitis has comp…

• CLINICAL_TRIALS trial_result · 2019-12-04
  Clinical Trial Update: Grass Pollen Allergen Immunotherapy Tablet (AIT) Time Course Study [Phase 2]

  Phase 2 clinical trial update for a grass pollen allergen immunotherapy tablet in allergic rhinitis; study completed with posted results.

• FDA approval · 2019-11-25
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Fluticasone Propionate from Hikma Pharmaceuticals USA Inc., under the ANDA program.

• FDA approval · 2019-11-14
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Glenmark's generic fluticasone propionate nasal spray.

• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Montelukast submitted by BluePoint Laboratories. The action pertains to an additional indication…