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Loratadine and montelukast FDA Approval Status

FDA Approved: No
Generic name: loratadine and montelukast
Company: Schering-Plough/Merck Pharmaceuticals
Treatment for: Allergic Rhinitis

This medicine is a single tablet combination of the active ingredients in Claritin (loratadine) and Singulair (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.

In June 2008, Schering-Plough Corp. and Merck & Co., Inc. announced the withdrawal of the New Drug Application (NDA) for the loratadine/montelukast combination tablet. The companies also terminated the Schering-Plough/Merck Pharmaceuticals respiratory joint venture.

Development timeline for loratadine and montelukast

DateArticle
Jun 27, 2008Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture
Apr 28, 2008Schering-Plough/Merck Pharmaceuticals Receives Not-ApprovableLetter from FDA for Loratadine/Montelukast
Aug 28, 2007Schering-Plough/Merck Pharmaceuticals Announce FDA FilingAcceptance of New Drug Application for Loratadine/MontelukastTablet

Further information

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