angeliq tabletten

MONTVILLE, N.J., September 15, 2004 -- Berlex, Inc., a U.S angeliq tabletten. affiliate of ScheringAG, Germany (NYSE:SHR), announced today that the U.S angeliq tabletten. Food and Drug Administration(FDA) issued an approvable letter for the novel hormone therapy Angeliq (drospirenoneand estradiol) tablets, pending the submission of additional manufacturing information angeliq tabletten. Angeliq is an oral therapy intended to help alleviate menopausal symptoms suchas hot flashes and vaginal dryness, which often interrupt a woman's day-to-dayfunctioning.

"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 hormonetherapy that combines estradiol with the novel progestin drospirenone,"said Reinhard Franzen, President and CEO of Berlex Laboratories angeliq tabletten. "Now isthe most important time for women to have a variety of options in managing theeffects of menopause angeliq tabletten. We designed Angeliq to contain hormones that are as closeas possible to the natural hormones a woman's body produces before menopause."

The Company will begin compiling the manufacturing data required by FDA immediately angeliq tabletten. "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 thelowest effective dose to meet treatment goals, the 0.5 mg drospirenone doseof 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 theAngeliq menopausal symptom trials, Berlex has agreed to withdraw the higherdoses of drospirenone from the New Drug Application, without prejudice, forAngeliq pending completion of studies investigating its potential blood pressurelowering effects.

Committed to addressing unmet medical needs, Berlex, a U.S angeliq tabletten. affiliate of ScheringAG, Germany (NYSE:SHR) , develops and markets diagnostic imaging agents, treatmentsin the areas of female health care and dermatology, as well as specialized therapeuticsfor life-threatening and disabling diseases in the fields of the central nervousand cardiovascular systems, oncology, and gastroenterology angeliq tabletten. Berlex has businessoperations in New Jersey, California and Washington.

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