Final appro for Mylan's Estradiol strengths

Mylan Laboratories says that the US Foods and Drug Administration has granted final approval for its supplemental Abbreviated New Drug Application for estradiol transdermal systems, 0.0375mg/day and 0.06mg/day. These products will be added to the four additional strengths of estradiol that Mylan is already marketing.

Estradiol transdermal systems are indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. They are the AB-rated generic equivalent of German drugmaker Schering AG US subsidiary Berlex' branded Climara Transdermal Systems.

Mylan says it is the first company to file a supplemental ANDA for estradiol transdermal systems at these doses and has, therefore, been awarded a 180-day period of marketing exclusivity for these two strengths.