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Article: Soriatane(R) Label Update Clarifies Use in Severe Psoriasis.
- Article from:
- PR Newswire
- Article date:
- May 8, 2003
CopyrightCOPYRIGHT 2003 PR Newswire Association LLC. 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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Soriatane(R) (acitretin), an oral medication that has been a staple of treatment for severe psoriasis for six years, has received approval for an enhanced, updated product label from the U.S. Food & Drug Administration (FDA), Roche announced today.
The major changes to the label include:
-- Amended indication for "severe psoriasis in adults," no longer saying
"including erythrodermic and pustular."
-- Clarification of how to use Soriatane safely in combination with
phototherapy
-- More rigorous pregnancy testing requirements and warnings about birth
defects
-- Clarified dosing flexibility, with a starting range of 25mg to 50mg,
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