Schering-Plough/MERCK Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast
The New Drug Application filing for loratadine/montelukast was accepted bythe FDA for standard review on August 26, 2007. The medicine is a singletablet that contains the active ingredients of CLARITIN (R) (loratadine) andSINGULAIR(R) (1) (montelukast sodium), both of which are indicated for therelief of symptoms of seasonal allergic rhinitis and perennial allergicrhinitis.
Schering-Plough/MERCK Pharmaceuticals is evaluating the agency's response.
The FDA decision does not impact the availability or continued use ofCLARITIN or SINGULAIR.
Schering-Plough received U.S. Food and Drug Administration (FDA) approvalon November 27, 2002, for the over-the-counter (OTC) sale of the originalprescription strength of CLARITIN Tablets.
SINGULAIR is indicated for the relief of symptoms of seasonal allergicrhinitis (SAR) in adults and children two years and older, and for the reliefof symptoms of perennial allergic rhinitis (PAR) in adults and children sixmonths and older. In clinical studies for both SAR and PAR, SINGULAIR wasgenerally 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 respiratoryinfection, sinus headache, cough, epistaxis, headache, otitis media,pharyngitis and increased ALT. SINGULAIR is contraindicated in patients withhypersensitivity to any of its components.
About Schering-Plough/MERCK Pharmaceuticals
Schering-Plough/MERCK Pharmaceuticals is a joint venture betweenSchering-Plough Corporation (NYSE: SGP) and Merck & Co., Inc. (NYSE: MRK)formed in May 2000 to develop and market a fixed-combination product thatwould combine loratadine and montelukast.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press releaseincludes certain "forward-looking statements" within the meaning of thePrivate Securities Litigation Reform Act of 1995, including statementsrelating to loratadine/montelukast. Forward-looking statements relate toexpectations or forecasts of future events. Schering-Plough does not assumethe obligation to update any forward-looking statement. Many factors couldcause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, productavailability, patent and other intellectual property protection, current andfuture branded, generic or over-the-counter competition, the regulatoryprocess, and any developments following regulatory approval, among otheruncertainties. For further details about these and other factors that mayimpact the forward-looking statements, see Schering-Plough's Securities andExchange Commission filings, including Part I, Item IA. "Risk Factors" inSchering-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 SecuritiesLitigation Reform Act of 1995. These statements are based on management'scurrent expectations and involve risks and uncertainties, which may causeresults to differ materially from those set forth in the statements. Theforward-looking statements may include statements regarding productdevelopment, product potential or financial performance. No forward-lookingstatement can be guaranteed and actual results may differ materially fromthose projected. Merck undertakes
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