Schering-Plough Corporation and MerckÂ Receives Not-Approvable Letter from FDA for Loratadine/Montelukast
KENILWORTH and WHITEHOUSE STATION, N.J., April 25 -- Schering-Plough/MERCK Pharmaceuticals (SPM) today confirmed that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for a proposed fixed combination of loratadine and montelukast for the treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion.
The New Drug Application filing for loratadine/montelukast was accepted by the FDA for standard review on August 26, 2007. The medicine is a single tablet that contains the active ingredients of CLARITIN Â® (loratadine) and SINGULAIRÂ® (1) (montelukast sodium), both of which are indicated for the relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.
Schering-Plough/MERCK Pharmaceuticals is evaluating the agency's response.
The FDA decision does not impact the availability or continued use of CLARITIN or SINGULAIR.
Schering-Plough received U.S. Food and Drug Administration (FDA) approval on November 27, 2002, for the over-the-counter (OTC) sale of the original prescription strength of CLARITIN Tablets.
SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older. In clinical studies for both SAR and PAR, SINGULAIR was generally well tolerated with a safety profile similar to that of placebo. Adverse events varied by age. The most commonly reported adverse events, occurring at a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment, were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased ALT. SINGULAIR is contraindicated in patients with hypersensitivity to any of its components.
About Schering-Plough/MERCK Pharmaceuticals
Schering-Plough/MERCK Pharmaceuticals is a joint venture between Schering-Plough Corporation (NYSE: SGP - News) and Merck & Co., Inc. (NYSE: MRK - News) formed in May 2000 to develop and market a fixed-combination product that would combine loratadine and montelukast.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to loratadine/montelukast. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item IA. "Risk Factors" in Schering-Plough's 2007 10-K/A.
MERCK FORWARD LOOKING STATEMENT: This press release contains "forward- looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.