First transdermal estrogen spray approved

August 6, 2007

EvaMist, from KV Pharmaceutical Co., has received approval from the FDA for the treatment of moderate to severe vasomotor symptoms due to menopause.

EvaMist, from KV Pharmaceutical Co., has received approval from the FDA for the treatment of moderate to severe vasomotor symptoms due to menopause. The product is the first estradiol transdermal spray to be approved by the agency. EvaMist therapy is initiated as a once-daily spray that can be increased to two or three sprays daily based on clinical response. Each metered-dose pump contains 8.1 ml, delivering 56 sprays, with each dose delivering 90 microliters of EvaMist, containing 1.53 mg estradiol. According to KV, the product will be launched during the second half of fiscal 2008. "KV bought the exclusive rights to EvaMist from Vivus Inc. earlier this year. Under the agreement, Vivus received $10 million up front and will receive an additional $140 million now that the drug has been approved."

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