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SP/Merck Combo Drug Accepted for Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Schering-Plough/Merck Pharmaceuticals’ (SPM) NDA for loratadine/montelukast has been accepted by the FDA for review. The drug is a single tablet that contains the active ingredients of Claritin (loratadine) and Singulair (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.

SPM is seeking marketing approval of loratadine/montelukast for treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion. If approved the medicine would be marketed as a prescription treatment by Schering-Plough/Merck Pharmaceuticals, a joint venture between Schering-Plough and Merck & Co.

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