Schering-Plough/MERCK Pharmaceuticals Receives Not-Approvable Letter from FDA for...

Schering-Plough/MERCK Pharmaceuticals Receives Not-Approvable Letter from FDA
for Loratadine/Montelukast

KENILWORTH and WHITEHOUSE STATION, N.J., April 25 /PRNewswire/ --
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 (R) (loratadine) and
SINGULAIR(R) (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.
About CLARITIN
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.
About SINGULAIR
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) and Merck & Co., Inc. (NYSE: MRK)
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.
(1) Singulair is a registered trademark of Merck & Co., Inc.
SOURCE Schering-Plough Corporation; Merck & Co., Inc.

Media: Lisa Ellen, Schering-Plough Corp., +1-908-298-7128, +1-201-506-0420
cell, or Skip Irvine, Merck & Co., Inc., +1-267-305-5397, +1-267-218-4477;
Investors: Joe Romanelli, Schering-Plough Corp., +1-908-298-7436, or Graeme
Bell, Merck & Co., Inc., +1-908-23-5185