Press Release
VIVUS Receives FDA Approval for Over-the-counter Marketing of Actis
MOUNTAIN VIEW, Calif.--(BW HealthWire)--Dec. 22, 2000--VIVUS, Inc. (Nasdaq: VVUS - news) today announced receipt of 510(k) approval from the Food and Drug Administration (FDA) for over-the-counter (OTC) marketing of ACTIS., an adjustable constriction band used to enhance the erection process in men with erectile dysfunction (ED). ACTIS received FDA marketing clearance in 1996 as a prescription device and was introduced into the marketplace in 1997.
``Our ACTIS OTC marketing efforts have already begun,'' commented Terry Nida, Vice President of Marketing at VIVUS. ``Our plan calls for selling ACTIS through major pharmacy channels and through e-commerce efforts. Given its safety record, we expect that the product will be well received by consumers.''
VIVUS has an agreement with ivpcare to handle phone (1-800-424-9002) and Internet (www.ivpcare.com) orders for ACTIS.
Internationally, ACTIS will be sold OTC by Abbott Laboratories (NYSE: ABT - news), which also markets VIVUS' erectile dysfunction prescription drug MUSE. (alprostadil).
VIVUS, Inc. is a specialty pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE. and ACTIS., two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories for the international marketing and distribution of its male ED products. VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA(TM), during the fourth quarter of 2000.
Contact:
VIVUS, Inc.
Dick Walliser, 650/934-5264
ir@vivus.com
www.vivus.com
or
Lippert/Heilshorn & Associates, Inc.
Investor Contacts:
Bruce Voss
bruce@lhai.com
Bonnie Feldman
bonnie@lhai.com
310/575-4848
or
Media Contacts:
Pamela Rigler
pamela@lhai.com
Carrie Kocik
carrie@lhai.com
212/838-3777
www.lhai.com
FOR UP TO DATE INFORMATION ON VIVUS, SEE THE VIVUS INVESTOR SITE. GET THE LATEST FACTS, OPINIONS, AND COMPETITIVE INFORMATION YOU NEED. vivusinvestor.net |
