MYLAN MENOPAUSE DRUG GRANTED ADDITIONAL APPROVAL

Generic drugmaker Mylan Laboratories announced that the FDA approved two additional dosage strengths of its menopause drug. The drug, estradiol transdermal systems, is a generic version of Berlex's climara transdermal systems. Berlex is the U.S. affiliate of Germany-based Schering AG.

The generic version, also aimed at treating symptoms associated with menopause, was approved for doses of 0.0375 mg and 0.06 mg. Mylan has a 180-day period of market exclusivity on the two dosage strengths for the drug.