Leishmaniasis

U.S. FDA grants VioQuest, U.S. Army orphan drug status for cutaneous leishmaniasis therapy

Published in TB and Outbreaks Week, February 20th, 2007

VioQuest Pharmaceuticals, Inc. (VQPH), a New Jersey-based biopharmaceutical company, in partnership with the U.S. Army, has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) for the active moiety of VQD-001, sodium stibogluconate, a treatment for the cutaneous form of leishmaniasis.

VioQuest has executed a Cooperative Research and Development Agreement (CRADA) with the U.S. Army relating to VQD-001's development and regulatory filing process for a new drug application (NDA) for the treatment of cutaneous leishmaniasis. VioQuest plans to submit an NDA to the FDA for VQD-001 this year based on trial data from clinical studies conducted...

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Source: TB and Outbreaks Week (2007-02-20)

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