Perennial Allergic Rhinitis

• EMA approval · 2026-03-02
  EMA Authorised: Azomyr (desloratadine) — Organon N.V.

  The European Medicines Agency authorised Azomyr, a desloratadine-containing medicine by Organon N.V., for allergic rhinitis (seasonal and pe…

• EMA approval · 2025-06-27
  EMA Authorised: Avamys (fluticasone furoate) — GlaxoSmithKline Trading Services Limited

  EMA has authorised Avamys (fluticasone furoate) nasal spray for allergic rhinitis, including seasonal and perennial forms.

• FDA approval · 2025-04-17
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to introduce Claritin Chewable Grape and Bubblegum (loratadine) by Bayer HealthCare LLC. This approv…

• FDA approval · 2025-04-03
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for montelukast sodium (ANDA 201515), enabling the approval of a gen…

• FDA approval · 2023-11-27
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for montelukast sodium from Dr. Reddy's Laboratories Limited, representing an additional approva…

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• FDA approval · 2023-11-21
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare Inc.'s Montelukast Sodium supplemental application for the generic product, enabling its labeling and market …

• FDA approval · 2023-10-02
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals, LLC's supplemental application for Montelukast Sodium, a generic product under an ANDA.

• FDA approval · 2023-08-08
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Fluticasone Propionate by Padagis Israel Pharmaceuticals Ltd, indicating an approved update to a…

• FDA approval · 2023-06-28
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental ANDA for Montelukast Sodium from Unichem Pharmaceuticals (USA), Inc., adding a generic Montelukast Sodium produc…

• EMA approval · 2023-06-01
  EMA Authorised: Desloratadine Actavis (desloratadine) — Actavis Group PTC ehf

  The EMA has authorised Desloratadine Actavis (desloratadine) for allergic rhinitis and urticaria indications in the European Union.

• FDA approval · 2023-03-09
  FDA Approved: RUGBY MOMETASONE FUROATE NASAL — Supplemental Application (Rugby Laboratories)

  FDA approved a supplemental application for Rugby Mometasone Furoate Nasal (mometasone furoate) submitted by Rugby Laboratories.

• FDA approval · 2022-12-27
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Children's Allegra Allergy containing fexofenadine hydrochloride, submitted by Chattem, Inc., to…

• FDA approval · 2022-01-19
  FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Montelukast (generic, Sandoz Inc), updating the product's approval status under the ANDA. Montel…

• FDA approval · 2022-01-19
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast sodium from Rising Pharma Holdings, Inc., enabling changes to its labeling or indica…

• FDA approval · 2022-01-19
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., updating the labeling under an existing ap…

• FDA approval · 2021-11-01
  FDA Approved: ASTEPRO ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for AStepro Allergy (azelastine HCl) from Bayer HealthCare LLC, resulting in updated labeling for th…

• FDA approval · 2021-10-15
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under an approved ANDA. This action …

• FDA approval · 2021-06-17
  FDA Approved: ASTEPRO ALLERGY — Original Application (Bayer HealthCare LLC.)

  FDA approved ASTEPRO ALLERGY (azelastine hydrochloride) under Bayer HealthCare LLC.'s original NDA, establishing its intranasal antihistamin…

• FDA approval · 2021-04-16
  FDA Approved: DYMISTA — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DYMISTA (azelastine hydrochloride and fluticasone propionate) submitted by Viatris Specialty LLC…

• FDA approval · 2021-02-18
  FDA Approved: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved Padagis Israel Pharmaceuticals' azelastine hydrochloride and fluticasone propionate nasal spray as an original ANDA, provid…

• FDA approval · 2020-11-24
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for montelukast sodium. This action grants regulatory approval for c…

• FDA approval · 2020-10-20
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, marking approval of a generic montelukast product und…

• FDA approval · 2020-10-05
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's supplemental application for montelukast sodium, authorizing the regulatory action for th…

• FDA approval · 2020-09-04
  FDA Approved: MONTELUKAST SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' Montelukast Sodium as a generic version of montelukast for the prevention and maintenance treatment of …

• FDA approval · 2020-08-14
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc. This action authorizes changes to the p…