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Article: ISTA Receives FDA Go-Ahead To Submit NDA For Vitrase.
- Article from:
- BIOWORLD Today
- Article date:
- November 4, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. 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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Staff Writer
In the wake of the disappointing news last month that Vitrase, a single injection for treating vitreous hemorrhage, did not meet its primary endpoint, ISTA Pharmaceuticals Inc. had good news to share Wednesday.
The Irvine, Calif.-based company reported that the FDA gave it the green light to proceed with the preparation and submission of clinical and other sections of its new drug application and will consider visual acuity as the primary endpoint.
ISTAEs stock (NASDAQ:ISTA) rose 52.4 percent Wednesday, or 44 cents, to close at $1.27.
oItEs fairly significant, obviously,o said ISTA CEO Vicente Anido, explaining that ISTA ...
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Article: FDA Grants ISTA Pharmaceuticals' Vitrase Five-Year Market ...
PR Newswire;
October 28, 2004 ;
700+ words
... ... determine whether any moiety in Vitrase is the same as any previously ... to the agency before the Vitrase was granted five-year exclusivity. Vicente Anido, Jr., Ph.D., President ... understand the change in Vitrase's exclusivity." ABOUT ...
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