Teva gains EU approval for oral contraceptive Zoely

There was good news for the world’s largest generics drugmaker Teva Pharmaceutical Industries (Nasdaq: TEVA) in its ambitions to get original branded products to the market, when the company announced that its new oral contraceptive, Zoely (nomegestrol acetate 2.5mg/17 beta-estradiol 1.5mg), has received marketing authorization in the European Union.

Zoely gained a positive recommendation from the European Medicines Agency advisory body earlier this year (The Pharma Letter March 21) and this approval clears the way to allow the product to be launched in Europe by the end of 2011, the company said.

Unlike currently available contraceptive pills, Teva explained, Zoely is a combined oral contraceptive (COC) tablet containing a unique monophasic combination of two 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 four day placebo dosing regimen.