FDA Approves SCE-A (Synthetic Conjugated Estrogens-A) Vaginal Cream

FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream

MONTVALE, N.J., December 01, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Synthetic Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream. SCE-A Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause. It is administered intravaginally at a dose of 1 gram daily for one week, followed by 1 gram intravaginally twice a week.

SCE-A Vaginal Cream will be shipped to trade customers and available by prescription to women in the first quarter of 2009. Duramed will initiate promotion to healthcare providers in the second quarter of 2009 utilizing direct sales force activities as well as other indirect marketing initiatives.

"SCE-A Vaginal Cream offers an additional treatment option to women and healthcare professionals," said Fred Wilkinson, Duramed's Chief Executive Officer. "With its unique indication and dosing regimen, it is designed to complement our existing line of plant-derived estrogen therapies for the treatment of post-menopausal symptoms."

According to the North American Menopause Society (NAMS), an estimated 10 to 40 percent of post-menopausal women suffer from symptoms related to vaginal atrophy(1). Two of the most common symptoms of vaginal atrophy are vaginal dryness and pain with intercourse(2). The symptoms of vaginal atrophy are most commonly associated with diminished estrogen levels that accompany menopause(1). If left untreated, vaginal atrophy may result in years of discomfort.(1)

SCE-A Vaginal Cream is indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy associated with menopause. The most common side effects in the clinical trials (>3%) were vulvovaginal infections, upper respiratory tract infection, headaches and hot flashes.

SCE-A Vaginal Cream should not be used in individuals with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of certain cancers; stroke or heart attack in the past year; currently having or having had blood clots or thromboembolic disease including stroke or myocardial infarction; or liver problems; allergy to SCE-A Vaginal Cream or any of its ingredients; or known or suspected pregnancy.

Menopause is the time in a woman's life when the menstrual period ceases and the ovaries permanently stop releasing eggs. Menopause is considered complete when a woman has been without her period for a full year. While some women experience no menopausal symptoms, others suffer severe symptoms that require treatment. Vasomotor symptoms (night sweats, hot flashes) and vaginal symptoms (such as vaginal dryness and pain with intercourse) are common menopausal symptoms. Although the majority of women experience "natural" or spontaneous menopause, some women may experience menopause due to a medical intervention such as surgery, chemotherapy or radiation.

(1) Menopause: The Journal of the North American Menopause Society

Vol. 14, No.3 pp. 357-358

(2) Bachman Ga, Ebert GA, Burd ID. Vulvovaginal Complaints. In: Lobo RA, ed. Treatment of the Postmenopausal Woman: Basic and Clinical Aspects. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 1999:195-201

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 26 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S. For more information, visit www.barrlabs.com.

CONTACT: Carol A. Cox, Barr Pharmaceuticals, +1-201-930-3720, ccox@barrlabs.com

Web site: http://www.barrlabs.com/

Company News On-Call: http://www.prnewswire.com/comp/089750.html

Ticker Symbol: (NYSE:BRL)

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Posted: December 2008

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