Mylan to market generic Climara

By Elaine Rigoli

Tampa, Fla., July 25 - The Food and Drug Administration has granted final approval for Mylan Technologies, Inc.'s supplemental abbreviated New Drug Application for Estradiol Transdermal systems, 0.0375 mg/day and 0.06 mg/day.

Estradiol, the AB-rated generic equivalent of Berlex's Climara Transdermal systems for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, will be added to the four additional strengths of Estradiol that Mylan is already marketing.

Mylan has been awarded a 180-day period of marketing exclusivity for these two strengths.

Mylan said it will launch this product soon.

Mylan is a pharmaceutical company located in Canonsburg, Pa.

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