Home » Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA
Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA
May 27, 2005
The FDA has accepted for filing and review Halozyme Therapeutics' new drug application (NDA) for Hylenex (formerly referred to as Enhanze SC).
Halozyme submitted the Hylenex NDA March 23, seeking approval for use as a spreading agent to facilitate the dispersion and absorption of other drugs.
The company previously announced in April 2005 that the FDA granted priority-review status to the Hylenex NDA, which sets the target date for initial FDA action within six months from the NDA submission date.
KEYWORDS Drug Pipeline Alert
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