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|August 02, 2011 5:01 a.m.|
|Teva Receives European Marketing Authorization for ZOELYTM Oral Contraceptive|
-- New OC Offers Innovative Combination which Includes a Natural Estrogen in a Convenient Dosing Regimen --
JERUSALEM, Aug 02, 2011 (BUSINESS WIRE) -- Teva Pharmaceutical Industries Ltd (NASDAQ: TEVA) announced today that its new oral contraceptive, ZOELYTM (NOMAC/E2 -nomegestrol acetate 2.5 mg/17B-estradiol 1.5 mg), has received a Marketing Authorization in the European Union (EU) for the prevention of pregnancy. This clears the way to allow the product to be launched in Europe by the end of 2011.
Unlike currently available contraceptive pills, ZOELYTM is a combined oral contraceptive (COC) tablet containing a unique monophasic combination of 2 steroid hormones; 17-beta estradiol, an estrogen that is structurally identical to the major estrogen produced by the ovaries of healthy non-pregnant women, and nomegestrol acetate, a highly selective progesterone-derived progestin. This innovative combination will be made available in a convenient 24 day active and 4 day placebo dosing regimen.
"The EU Marketing Authorization for ZOELYTM marks an important step in creating a strong women's healthcare franchise for Teva in Europe," said Dr Gerard van Odijk, President and CEO of Teva Europe. "The acquisition of Théramex in January this year gives us a platform to leverage our capability in women's healthcare, and the launch of ZOELYTM is part of our developing business in this area."
Teva holds exclusive marketing rights for ZOELYTM in France, Italy, Belgium and Spain and expects the first launch by the end of the year.
The approval of ZOELYTM applies to the 27 EU Member States plus Norway, Iceland and Liechtenstein.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
SOURCE: Teva Pharmaceutical Industries Ltd.