Teva wins FDA approval for generic birth control drug

Teva Pharmaceutical Industries, a generic pharmaceutical company, has received the FDA approval for the company’s abbreviated new drug application to market its generic version for Bayer Healthcare Pharmaceuticals’s oral contraceptive Yaz tablets.

As the first company to file an abbreviated new drug application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

In 2008, Teva’s subsidiary Barr Pharmaceuticals entered into a supply and licensing agreement with Bayer. Under this agreement, Teva has the right to launch an authorized generic version of Yaz on July 1, 2011, or earlier in certain circumstances.

Teva Pharmaceutical, a pharmaceutical company for generic medicines. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.

Bayer HealthCare Pharmaceuticals is US based pharmaceuticals operation of Bayer HealthCare, an affiliate of Bayer AG. Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the US, Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company is focused at discovering and manufacturing products to improve human health worldwide by diagnosing, preventing and treating diseases.