FDA Approves Progestin Contraceptive Yasmin

berlex-laboratoriesBerlex Laboratories has announced FDA approval of their new low-dose, monophasic oral contraceptive, the first to contain the unique progestin, drospirenone. Drospirenone is different from the progestins currently available in other oral contraceptives.

As an analogue of spironolactone, which is widely used by Ob/Gyns for many women, drospirenone exhibits antimineralocorticoid activity which influences the regulation of water and electrolyte balance in the body.

This activity may increase potassium levels in some patients.

Therefore, it is recommended that women with kidney, liver or adrenal disease should not take YASMIN, because this activity could cause serious heart and health problems.

Patients taking drugs that could increase potassium should consult their health care professional before taking YASMIN.

“YASMIN is the second major innovation that we’ve introduced to the U.S. market this year. Its market entry, along with the introduction of the levonorgestrel-releasing intrauterine system MIRENA early this year, represents further expansion of the Berlex leadership in contraception,” said Reinhard Franzen, Vice President and General Manager, Female Healthcare, Berlex Laboratories, Inc. “Because of the unique clinical pharmacology of YASMIN, we believe this product will provide women with an important new option in contraception.”

Over 500,000 women in Europe are currently using YASMIN, where the product has been available in several countries, including Germany, since November of 2000. Berlex Laboratories, Inc., a U.S. affiliate of Schering AG, Germany, researches, manufactures and markets ethical pharmaceuticals in five strategic areas: Female Healthcare, Diagnostic Imaging, Dermatology, Oncology and Therapeutics for life-threatening and disabling diseases.

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