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FDA Approves Divigel(R) for Treatment of Hot Flashes Linked With Menopause

lest application area compared to all other available gel or lotion estrogen products.

"We are pleased that the FDA recognizes the value that this convenient, low-dose therapy brings to women that are experiencing uncomfortable hot flashes associated with menopause," said Mark Evenstad, President, Upsher-Smith Laboratories, Inc. "Our organization has worked closely with the FDA on the approval of this therapy, and we look forward to making the product commercially available in July 2007."

Important Safety Information for Patients

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

Estrogens increase the chance of getting cancer of the uterus. 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 (womb). 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.

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