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FDA approves Vitrase for use as a spreading agent.
2004 JUN 2 - (NewsRx.com & NewsRx.net) -- ISTA Pharmaceuticals, Inc., (ISTA) announced that the U.S. Food and Drug Administration (FDA) has approved ISTA's new drug application (NDA) for Vitrase (hyaluronidase for injection; lyophilized, ovine) for use as a spreading agent to facilitate the dispersion and absorption of other drugs.
This approval removes hyaluronidase from the FDA's drug shortage list where it has been listed since 2001. ISTA's Vitrase is a formulation of highly purified, preservative-free ovine hyaluronidase, which has been studied extensively in several ophthalmic conditions.
H. Dunbar Hoskins, Jr., MD, executive vice president of the American Academy of Ophthalmology, commented, "The Academy of Ophthalmology is pleased that ISTA Pharmaceuticals has made this drug available after a long absence from the market. Many ophthalmologists will find Vitrase to be highly useful in their surgical procedures." Prior to 2001, a bovine-derived, thimerosal-preserved form of hyaluronidase was reportedly used as a spreading agent in conjunction with other drugs in over 750,000 ophthalmic surgeries.
The "Indications and Use" section of the newly approved labeling state "Vitrase is indicated as an adjuvant to increase the absorption and dispersion of other ...
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...currently FDA approved for use as a spreading agent for hypodermoclysis and as an adjunct...presentations relating to Vitrase as a spreading agent at major, clinically oriented meetings...only purified, preservative-free spreading agent and adjunct on the market. We believe...
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- Magazine article from: BIOWORLD Today Coghill, Kim May 7, 2004 700+ words
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- Press release article from: PR Newswire August 2, 2004 700+ words
...lyophilized, ovine) for use as a spreading agent. The Company believes that...vial size would be optimal for spreading agent use. Vicente Anido, Jr...convenience of using Vitrase as a spreading agent by ophthalmologists and increase...
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- Magazine article from: BIOWORLD Today Coghill, Kim February 9, 2004 700+ words
...drug application for Vitrase as a spreading agent by May 5, a 90-day extension on...NDA submitted late last year. As a spreading agent, Vitrase, a formulation of purified...for the product. If approved as a spreading agent, the firm would like the FDA to allow...
- Review of ISTA Pharmaceuticals' New Drug Application for Vitrase(R) for Use as...
- Press release article from: PR Newswire February 6, 2004 700+ words
...announced that the U.S. Food & Drug Administration (FDA) plans to complete review of ISTA's Vitrase for Use as a Spreading Agent New Drug Application (NDA) by May 5, 2004, a 90-day extension of the original action date. According to the FDA...
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...Delivery, Vaccine Development, Vaccine Efficacy, Immunology, and Immunotherapy. This article was prepared by Vaccine Weekly editors from staff and other reports. Copyright 2004, Vaccine Weekly via NewsRx.com & NewsRx.net.
Source: HighBeam Research, FDA approves Vitrase for use as a spreading agent.