FDA Approves OXYTROL® FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women

  FDA Approves OXYTROL® FOR WOMEN, the First Over-the-Counter Treatment for
                         Overactive Bladder in Women

New Over-the-Counter Option for More Than 20 Million Women with Overactive

PR Newswire


WHITEHOUSE STATION, N.J., Jan. 25, 2013 /PRNewswire/ --Merck (NYSE: MRK),
known as MSD outside the United States and Canada, announced today that the
U.S. Food and Drug Administration (FDA) has approved OXYTROL FOR WOMEN
(oxybutynin transdermal system, 3.9 mg/day), the first and only
over-the-counter (OTC) treatment for overactive bladder in women.OXYTROL FOR
WOMEN addresses an important unmet need for overactive bladder, or OAB, a
condition that affects more than 20 million American women.Despite the fact
that OAB is a treatable medical condition, more than 80 percent of women with
OAB do not seek treatment.

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OAB is characterized by a number of symptoms that can be physically burdensome
and emotionally draining, including a strong urge to urinate right away and
the need to urinate more often than usual, with or without leakage. The
majority of women who suffer develop the condition between the ages of 45 and
60 years old. According to the National Association for Continence, although
OAB is a treatable medical condition, most women do not discuss their symptoms
with a doctor and assume that the symptoms are a normal part of aging. Rather
than seek treatment, many women try to manage their condition with coping
strategies that include wearing pads and/or dark clothing, mapping out the
nearest toilets, and avoiding social interactions outside the home.

"The approval of OXYTROL FOR WOMEN as an OTC treatment option is an exciting
development for the millions of women who struggle to deal with OAB every
day," said Eman Elkadry, M.D., Clinical Instructor Harvard Medical School;
Boston Urogynecology Associates at Mount Auburn Hospital. "This effective,
over-the-counter treatment offers women an option to independently
managetheir condition and achieve a newfound sense of control. The approval
also provides recognition that this is a real medical disorder that can be

The FDA approval of the prescription to OTC switch was based on data from
several well-designed studies that demonstrated a woman's ability to correctly
recognize OAB symptoms, understand key safety messages on the label, judge if
the product is right, or wrong, for her, and appropriately use OXYTROL FOR
WOMEN in an unsupervised setting. The FDA considers this a partial switch, as
OXYTROL will remain available by prescription only for the treatment of OAB in
men.The approval follows an FDA Advisory Committee meeting that occurred in
November 2012.

"Merck is dedicated to increasing access to safe and effective treatments to
help people better manage their health conditions and improve the quality of
their lives," said Bridgette P. Heller, Executive Vice President and
President, Merck Consumer Care. "We are proud to bring OXYTROL FOR WOMEN
over-the-counter and provide a treatment option that can help women with OAB
recognize and treat their symptoms."

Merck anticipates that OXYTROL FOR WOMEN will be available to customers in
Fall 2013.

Please visit www.OxytrolForWomen.com for more information.


OXYTROL^® FOR WOMEN is the only over-the-counter treatment available for
overactive bladder in women. The OXYTROL FOR WOMEN patch provides transdermal
delivery of oxybutynin, an active ingredient used to treat OAB for more than
30 years. Each OXYTROL FOR WOMEN patch delivers 3.9 mg of oxybutynin per day
for a continuous four days and nights.

Merck licensed the exclusive rights to market, distribute and sell OXYTROL as
an OTC treatment for OAB from Actavis, Inc. (NYSE: ACT), formerly known as
Watson Pharmaceuticals, Inc.

OXYTROL^® (oxybutynin transdermal system) is a registered trademark of Watson
Pharma, Inc.

About Merck Consumer Care

Today's Merck is a global healthcare leader working to help the world be
well. Merck Consumer Care is a subsidiary of Merck & Co., Inc. Each day,
millions count on one or more of our industry-leading brands that help prevent
or treat various common conditions. These include household names such as
CLARITIN^® for allergies, COPPERTONE^® for sun care, DR. SCHOLL'S^® for foot
care, and many more. For more information, visit www.merck.com and connect
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This news release includes "forward-looking statements" within the meaning of
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Reform Act of 1995. Such statements may include, but are not limited to,
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The following factors, among others, could cause actual results to differ from
those set forth in the forward-looking statements: the possibility that all of
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be realized, or will not be realized within the expected time period; the
impact of pharmaceutical industry regulation and health care legislation in
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and other protections for innovative products; and the exposure to litigation
and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
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Additional factors that could cause results to differ materially from those
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and Exchange Commission (SEC) available at the SEC's Internet site

SOURCE Merck Consumer Care

Website: http://www.oxytrolforwomen.com
Contact: Media Contacts: Amy Rose, +1-908-328-3957; Pam Eisele,
+1-908-423-5042; Investor Contacts: Carol Ferguson, +1-908-423-4465; Justin
Holko, +1-908-423-5088
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