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FDA Issues Approvable Letter for Drospirenone and Estradiol Tablets

MONTVILLE, N.J., Sept. 15 /PRNewswire-FirstCall/ -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE:SHR) , announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter for the novel hormone therapy ANGELIQ(R) (drospirenone and estradiol) tablets, pending the submission of additional manufacturing information. ANGELIQ is an oral therapy intended to help alleviate menopausal symptoms such as hot flashes and vaginal dryness, which often interrupt a woman's day-to-day functioning.

"In a market that now requires treatment to be highly individualized, we will be proud to provide women with a new option -- the first and only hormone therapy that combines estradiol with the novel progestin drospirenone," said Reinhard Franzen, President and CEO of Berlex Laboratories. "Now is the most important time for women to have a variety of options in managing the effects of menopause. We designed ANGELIQ to contain hormones that are as close as possible to the natural hormones a woman's body produces before menopause."

The Company will begin compiling the manufacturing data required by FDA immediately. "We are optimistic that we will obtain final approval for ANGELIQ in 2005," says Franzen.

Once available, ANGELIQ will contain 0.5 mg drospirenone and 1 mg estradiol.

"Given current hormone therapy prescribing recommendations to use the lowest effective dose to meet treatment goals, the 0.5 mg drospirenone dose of ANGELIQ will be an excellent choice for the treatment of menopausal symptoms," says Marie Foegh, MD, DSc, Vice President, Medical Affairs at Berlex Laboratories.

Since the 0.5 mg is the lowest effective dose of drospirenone studied in the ANGELIQ menopausal symptom trials, Berlex has agreed to withdraw the higher doses of drospirenone from the New Drug Application, without prejudice, for ANGELIQ pending completion of studies investigating its potential blood pressure lowering effects.

Source: Berlex, Inc.

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