MHRA expands UK label for MSD's Singulair

11 June 2006

The UK drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has expanded the label for Merck Sharpe and Dohme's oral asthma treatment, Singulair (montelukast). The firm's antileukotriene is now approved in the UK as an alternative treatment for low-dose inhaled corticosteroids for children aged two-14 years with mild persistent asthma who do not have a recent history of serious asthma attacks.

The move extend's the drug's existing license for use as an add-on therapy in those patients with mild-to-moderate asthma who are inadequately controlled on either ICS or "as needed" short-acting beta agonist therapy. Mike Thomas, a UK-based hospital and general practitioner, welcomed the move saying that the agent is a "much needed alternative option" for treating the condition.

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