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Vivus Receives FDA Approval of Evamist

July 30, 2007

Vivus announced that it has received FDA approval for the marketing of Evamist, a metered-dose transdermal estradiol spray for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

According to Vivus, Evamist is the first estradiol transdermal spray approved by the agency.

Vivus previously announced the agreement with KV Pharmaceutical Company for the grant of a sublicense of exclusive rights and sale of assets related to Evamist March 30.

Under the terms of the transaction, the company said it is also eligible to receive an additional $140 million cash payment upon the approval of the Evamist’s new drug application.

The company said it expects to transfer and assign the NDA to KV by Aug. 3.