Skip to Content

Loratadine and montelukast 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 Status and FDA Approval Process for loratadine and montelukast

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.