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Spear Pharmaceutical Inc.'s ANDA for Fluorouracil Cream 5%
Date:5/20/2008

s bioequivalence requirements." Like thousands of generic drugs that have been approved over the years, the FDA approved the Spear product based on precedent and pursuant to its well established scientific, medical, and statistical review procedures for determining bioequivalence.

Despite this very clear position of the FDA, and the fact that the Courts do not overrule the FDA on matters of science, Valeant, in a further effort to block generic competition, sued the FDA asking the court to substitute its scientific judgment for that of the FDA.

Because of certain administrative issues regarding the FDA's record, Spear has voluntarily agreed not to ship additional product until the end of May, at which time we fully expect that the FDA will resolve its administrative issues and Spear shipments of Fluorouracil Cream will resume.

http://www.spearpharma.com

Stephen Basile

Senior Vice President, Sales and Marketing

Spear Pharmaceuticals, Inc.

973-895-6447 phone

basile@spearpharma.com


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SOURCE Spear Pharmaceuticals, Inc.
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