This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

FDA Approves OXYTROL® FOR WOMEN, The First Over-the-Counter Treatment For Overactive Bladder In Women

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.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/60157-fda-approves-merck-oxytrol-for-women-overactive-bladder-treatment

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 manage their condition and achieve a newfound sense of control. The approval also provides recognition that this is a real medical disorder that can be addressed."

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.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,279.74 +13.75 0.08%
S&P 500 2,010.40 -0.96 -0.05%
NASDAQ 4,579.7870 -13.6380 -0.30%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs