By Erin McCarthy
Impax Laboratories Inc. (IPXL) said the U.S. Food and Drug
Administration issued several inspectional observations after
inspecting the company's Taiwan facility for the Parkinson's
treatment Rytary.
The FDA performed the general inspection and a preapproval
inspection for the treatment earlier this month. The agency issued
10 observations from the inspection, and the company will respond
to them within 15 business days, Impax said.
Shares dropped more than 17% in premarket trading.
It is unknown what impact the inspection will have on Rytary's
October review date, and the FDA will not reveal the classification
or status of the observations until it has received the company's
response, Impax added.
Impax in April resubmitted its new drug application for the
Parkinson's disease treatment to the FDA with updated safety and
stability information. Rytary, a long-gestating drug, hasn't been
approved or licensed in any country. Impax first submitted a new
drug application for Rytary to the FDA in December 2011.
Last year, Impax and GlaxoSmithKline PLC (GSK) terminated their
partnership to develop and market Rytary outside the U.S. and
Taiwan following delays in regulatory approval.
Write to Erin McCarthy at erin.mccarthy@wsj.com
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