Loratadine/montelukast

Drug Profile

Loratadine/montelukast

Alternative Names: Claritin/Singulair; Montelukast/loratadine

Latest Information Update: 22 Mar 2010

Price : $50

At a glance

  • Originator Schering-Plough/Merck Pharmaceuticals
  • Class Acetates; Antiallergics; Antiasthmatics; Dibenzocycloheptenes; Nonsedating antihistamines; Piperidines; Quinolines
  • Mechanism of Action Histamine H1 receptor antagonists; Leukotriene D4 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No

Highest Development Phases

  • Discontinued Seasonal allergic rhinitis

Most Recent Events

  • 27 Jun 2008 Schering-Plough/Merck Pharmaceuticals withdraws NDA for loratadine/montelukast in Seasonal allergic rhinitis
  • 25 Apr 2008 Schering-Plough/Merck Pharmaceuticals receives non-approvable letter from the FDA for loratadine/montelukast in Seasonal allergic rhinitis
  • 30 Aug 2007 Preregistration for Seasonal allergic rhinitis in USA (PO), FDA has accepted filing
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