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Upsher-Smith Launches New Website for Divigel(R), a Bioidentical and FDA-Approved Hormone Therapy for Moderate to Severe Hot Flashes, Including Night Sweats, Associated with Menopause

Friday, September 18, 2009 General News J E 4
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MAPLE GROVE, Minn., Aug. 27 Today Upsher-Smith Laboratories, Inc. launched a new website for its transdermal, bioidentical and FDA-approved hormone therapy product Divigel(R) (estradiol gel) 0.1%, www.divigel.com. The website offers a comprehensive resource of information to women who are seeking to educate themselves about menopause, its common symptoms of hot flashes and associated night sweats, and more importantly how to gain relief.

"www.divigel.com offers key facts about menopause, including symptoms, treatments, risks and benefits of estrogen therapy, as well as answers to commonly asked questions," says Mark Evenstad, president, Upsher-Smith. "We want to provide women with a credible source for up to date information about menopause. There are so many menopause myths and opinions published everyday, it is important for women to have an accurate resource to gain knowledge and a place they can confidently refer their friends and coworkers. We believe this website provides the latest scientific knowledge to help women become empowered in order to speak candidly with their healthcare professional about their menopause symptoms and what treatment options may be available for them."

Features of the new user-friendly website include the latest resource center, valuable educational tools, and special patient offers, including an opportunity to request a non-medicated gel sample. This website also offers a comprehensive, printer-friendly patient education brochure and "Getting Started" pamphlet about menopause and Divigel(R), available in both English and Spanish. Saving money on a Divigel(R) prescription is just a mouse click away. Just "click and print" a Patient Savings Card and save up to $20 on each Divigel(R) prescription for the next year.

About Divigel(R)

Divigel(R) is a bioidentical, transdermal gel that is FDA approved for the treatment of moderate to severe vasomotor symptoms associated with menopause. The estrogen in Divigel(R) is derived from plant sources and is identical to the primary estrogen produced by a woman's ovaries before menopause. Divigel(R) is a quick-drying gel that is odorless when dry, and is available in convenient, individual-use packets. One packet of gel is applied daily to an area that measures approximately 5 x 7 inches on the thigh, the smallest application area compared to all other available gel or lotion estrogen products.1-4 After the gel is applied, it absorbs directly into the bloodstream without having to pass through the liver.

Divigel(R) was approved by the U.S. Food and Drug Administration (FDA) in June 2007.

Important Safety Information for Patients

The following are not all the possible risks for Divigel(R). Please see the full Prescribing Information and talk to your healthcare provider.

Estrogens increase the chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer and blood clots.

Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.

Do not use estrogen products, including Divigel(R), if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel(R) ingredients or think you may be pregnant.

The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. Less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease and ovarian cancer.

In Divigel(R) clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you.

Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel(R). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-654-2299 or visit www.divigel.com

About Upsher-Smith Laboratories, Inc.

Upsher-Smith Laboratories, Inc. is a rapidly growing pharmaceutical company that manufactures and markets both prescription and consumer products. Privately held since 1919, the company strives to recognize the unmet healthcare needs of our customers. Upsher-Smith prides itself in providing safe, effective, and economical therapies to the ever-challenged healthcare environment. For additional information about Upsher-Smith, visit www.upsher-smith.com.

References: 1. Divigel(R) [package insert]. Minneapolis, MN: Upsher-Smith Laboratories, Inc.; 2007. 2. Estrasorb(R) [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC; 2008. 3. EstroGel(R) [package insert]. Herndon, VA: Ascend Therapeutics, Inc.; 2007. 4. Elestrin(TM) [package insert]. Lincolnshire, IL: BioSante Pharmaceuticals, Inc.; 2007.

SOURCE Upsher-Smith Laboratories, Inc.
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