Menopause, also known as the Change of life or climacteric, is a stage of the human female reproductive cycle that occurs as the ovaries stop producing estrogen, causing the reproductive system to gradually shut down. A clinical diagnosis that is based on the permanent cessation of menses.

Duramed's Enjuvia Tablets Receives Two New FDA Approvals

Menopause :: Duramed's Enjuvia Tablets Receives Two New FDA Approvals

Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL), announced that the Company has received two U.S. Food and Drug Administration (FDA) approvals related to its ENJUVIA(TM) (synthetic conjugated estrogens, B) product.

The FDA has approved the Company's supplemental New Drug Application (sNDA) for 0.9 mg tablet strength, which will be added to the Company's existing ENJUVIA product line that includes the 0.3 mg, 0.45 mg, 0.625 mg, and 1.25 mg tablet dosage strengths.

In addition, ENJUVIA is also the first and only oral estrogen that has been approved by FDA to treat moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. When prescribing for the treatment of moderate-to-severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. ENJUVIA is already indicated for the treatment of moderate-to- severe vasomotor symptoms associated with menopause.

"The approval of the 0.9 mg tablet further expands the ENJUVIA line and will provide healthcare professionals with additional dosing flexibility for their patients using oral estrogen therapy," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "The approval of the additional indication for ENJUVIA provides female healthcare providers with yet another option for addressing symptoms associated with menopause and may make ENJUVIA an appropriate therapeutic option for a larger group of menopausal patients. Both approvals expand the value of the ENJUVIA therapy option for health care providers and patients and our Women's Health Sales Force will be detailing the additional strength and expanded indication."

The Company plans to launch the ENJUVIA 0.9 mg tablet and the new indication for the ENJUVIA product line in October 2007 at the North American Menopausal Society Annual Meeting. Duramed currently promotes ENJUVIA to healthcare providers using its 250-person Women's Healthcare Sales Force.

Duramed's ENJUVIA is a plant-derived formulation, ENJUVIA contains a blend of 10 synthetic estrogenic substances including delta 8,9 - dehydroesterone sulfate (DHES). ENJUVIA uses a unique delivery system, consisting of Surelease(R) technology with a cellulose-based polymer tablet design, to provide slow release of estrogens over several hours.

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