Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration has granted final approval for Mylan Technologies Inc.'s (MTI) supplemental Abbreviated New Drug Application for Estradiol Transdermal Systems, 0.0375 mg/day and 0.06 mg/day. These products will be added to the four additional strengths of Estradiol Transdermal Systems 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 Berlex's Climara Transdermal Systems®.
Mylan is the first company to file a supplemental ANDA for Estradiol Transdermal Systems, 0.0375 mg/day and 0.06 mg/day, and has been awarded a 180-day period of marketing exclusivity for these two strengths.
Mylan expects to launch this product shortly.
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