FDA Issues Inspection Observations of Impax's Taiwan Facility

By Dow Jones Business News, 

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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This article appears in: News Headlines

Referenced Stocks: GS7 , GSK , IPXL

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