FDA approves KV's menopause drug

ST. LOUIS, July 30 (UPI) -- KV Pharmaceutical said Monday the U.S. Food and Drug Administration approved EvaMist for treating hot flashes due to menopause.

KV, which acquired exclusive U.S. rights to EvaMist from Vivus, plans to market the drug as part of the women's health product line of its subsidiary, Ther-Rx.

Under the terms of the deal for EvaMist's marketing rights, Vivus is eligible to receive a $140 million payment upon the approval of the new drug application and two one-time milestone payments of up to $30 million.

"We believe our existing presence in the women's health market and our specialized focus on the OB/GYN community through our dedicated sales force will allow us to successfully promote the benefits of EvaMist to physicians and patients," said Marc Hermelin, KV's chairman of the board and chief executive officer.

"We look forward to launching this product during the second half of fiscal 2008 and to its contribution to the growth of our branded business moving forward," Hermelin added.