FDA issued a "not approvable" letter to Schering-Plough/Merck & Co. April 25 that applies to an NDA for a fixed-dose combination of loratadine/montelukast.

The drug combines Merck's leukotriene antagonist Singulair (montelukast) and Schering-Plough's Claritin (loratadine). The drugs are approved and indicated to relieve allergy symptoms, both seasonal and perennial.

On March 27, FDA posted an early communication of an ongoing safety review of montelukast on its Web site. FDA stated that adverse event reports could associate the drug with suicide attempts.

Merck said in a same-day statement that it provided a cumulative analysis to FDA of more than 40 randomized, double-blind, placebo-controlled clinical trials including over 11,000 adults and children who used Singulair.

The firm had updated the drug's label in October 2007 to include warnings on suicidal thinking and behavior.

"These actions were based on a very limited number of post-marketing adverse event reports," the firm said.

FDA accepted the NDA filing Aug. 26, 2007, for the combination to relieve allergic rhinitis symptoms in patients with nasal congestion. It had a standard review with a user fee date of June 28.

The firms said they are evaluating the agency's response.

- Pamela Taulbee (p.taulbee@elsevier.com)

Merck-Schering Claritin/Singulair Combo “Not Approvable” At FDA

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