The review period for Shire plc’s new drug application (NDA) for MESAVANCE™ has been extended by 90 days by the USFDA.
An extension sought by the USFDA in order to allow additional time to review the supplemental Phase I data recently submitted by Shire.
The new action date for the said NDA is January 21, 2007.
According to Matthew Emmens, Chief Executive Officer of Shire (Nasdaq: SHPGY, LON: SHP):
"Shire will continue to work closely with the FDA during this brief extension of the MESAVANCE NDA review. We still anticipate MESAVANCE will be approved and launched in the US and Europe during the first quarter 2007."
MESAVANCE™ is Shire's pipeline product for inflammatory bowel disease (IBD).
Source: Shire plc Press Release
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