Vivelle-Dot (Estradiol Transdermal System) Now Approved In New, Low Dose For Postmenopausal Osteoporosis Prevention


MIAMI, FL — May 21, 2002 —

Don’t blink or you might miss it! About the size of a dime, Vivelle-Dot’s newest dosage strength of 0.025 mg/day is not only the smallest estrogen replacement patch in the world, but also the newest weapon in the fight against postmenopausal osteoporosis.

 Vivelle-Dot is now approved in the 0.025 mg/day dosage strength, providing among the lowest effective ERT dosage strengths available in the U.S. for the prevention of postmenopausal osteoporosis.

This new, low dose patch is small, thin, nearly translucent and easy to apply. Vivelle-Dot’s original four dosage strengths (0.0375, 0.05, 0.075 and 0.1 mg/day) available for the treatment of menopausal symptoms since May 1999, are now also indicated for prevention of postmenopausal osteoporosis.

Vivelle-Dot 0.025 mg/day utilizes state-of-the-art proprietary DOT Matrix technology. The new product delivers estradiol, the primary estrogen produced by the ovaries, through a patch that is applied twice weekly.

Although all original four doses of Vivelle-Dot (0.0375, 0.05, 0.075 and 0.1 mg/day) are currently available, its newest and lowest dose 0.025 mg/day is expected to first become available in August 2002.

 “Many women of postmenopausal age are at risk for osteoporosis. With estrogen replacement therapy and simple lifestyle changes, including regular weight-bearing exercise and adequate intake of calcium and vitamin D, osteoporosis is a preventable problem,” said Karen Cashmere, Director of Women’s Health Marketing at Noven Pharmaceuticals, Inc.

“We are pleased to provide women with a new option in the fight against bone disease. Our new patch is an innovative solution — it’s not only tiny, but offers sustained estrogen delivery.”

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