FDA approves Teva's birth-control generic

JERUSALEM The Food and Drug Administration has approved Teva Pharmaceutical Industries’ version of a birth-control drug by Bayer HealthCare, Teva announced this week.

Teva said the FDA had approved its version of Yaz (drospirenone and ethinyl estradiol) tablets. Teva is the first company to file for regulatory approval with a paragraph IV certification, giving it six months of market exclusivity.

Sales of Yaz were about $616 million in 2008, according to IMS Health data.

Under an agreement last year between Bayer and Teva subsidiary Barr Pharmaceuticals, Teva has the right to launch an authorized generic version of Yaz in July 2011.