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Article: Gilead Sciences Announces Submission of Vistide New Drug Application for the Treatment of CMV Retinitis.
- Article from:
- Business Wire
- Article date:
- October 3, 1995
CopyrightCOPYRIGHT 1995 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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FOSTER CITY, Calif.--(HealthWire)--Oct. 3, 1995--Gilead Sciences, Inc. (Nasdaq: GILD) announced today it has submitted a New Drug Application (NDA) for VISTIDE(TM) (cidofovir intravenous) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.
The application to market VISTIDE in the United States was submitted to the U.S. Food and Drug Administration (FDA) for the first-line intravenous treatment of CMV retinitis, a disease that, if untreated, progresses rapidly and ultimately can lead to blindness.
The submission includes pivotal efficacy and safety data from two controlled, randomized clinical studies conducted in a broad spectrum of ...