Estradiol spray for menopause was granted marketing approval from FDA.
Vivus 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. Evamist is the first estradiol transdermal spray approved by the FDA, reports the company.
Vivus previously announced an agreement with KV Pharmaceutical for the grant of a sublicense of exclusive rights and sale of assets related to Evamist on March 30, 2007. At the closing of the transaction in May, Vivus received a cash payment of $10 million. Under the terms of the agreement, Vivus is also eligible to receive an additional $140 million cash payment upon the approval of the NDA for Evamist. The payment is expected five days after the transfer of the NDA to KV. Vivus is expected to transfer and assign the NDA to KV by August 3, 2007.
In the future, Vivus may also receive certain one-time milestone payments of up to $30 million based on net annual sales of Evamist.