FDA extends review of Impax Labs Parkinson's drug

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Associated Press

Posted on October 12, 2012 at 9:00 AM

Updated Friday, Oct 12 at 10:02 AM

HAYWARD, Calif. (AP) — Impax Laboratories Inc. said Friday that the Food and Drug Administration is extending a review of its Parkinson's disease drug Rytary by three months until Jan. 21.

The FDA was expected to make a decision by Oct. 21. Impax said the agency asked it for more information about the drug, and it is taking additional time to review that data.

Impax developed Rytary through a partnership with British drugmaker GlaxoSmithKline PLC. GlaxoSmithKline will market Rytary outside the U.S. and Taiwan. The drug has not been approved in any markets to date.

Shares of Impax Laboratories rose 2 cents to $26.07 in midday trading Friday. They traded at a 52-week high of $27.25 on Oct. 2 and as low as $16.50 last November.

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