AP News

Impax Labs falls aftermarket on new FDA concerns


HAYWARD, Calif. (AP) — Generic drug maker Impax Laboratories Inc. said Friday that the Food and Drug Administration found new problems at its U.S. manufacturing plant. The news sent its shares plunging in aftermarket trading.

The company said FDA inspectors identified 12 different problems the company needs to fix.

The FDA sent Impax a warning letter in January 2011 based on an inspection of the Hayward, Calif., plant, and found other problems in a March 2012 inspection. The dozen latest problems include three issues that were described in the warning letter.

Impax said it has worked hard to make sure it meets the FDA's standards and is disappointed with the results of the latest inspection. The company said it will respond to the FDA within 15 business days, as required by law, and plans to address the problems the FDA identified.

Shares of Impax dropped $4.10, or 20.5 percent, to $15.90 in aftermarket trading. The shares last traded at that price in August 2011.

The original warning letter cited problems in Impax's sampling and testing, its production record review, and the process it used to determine why manufacturing batches did not meet quality specifications. The company withdrew some manufacturing lots of a cholesterol drug as a result of the warning.

During the March 2012 inspection, the FDA said the original problems had been addressed, but it found problems in its quality control laboratory.

Impax needs to address the problems to gain approval of Rytary, a drug designed to treat symptoms of Parkinson's disease.

The company said it does not know if any further action will be taken as a result of the inspection.

Shares of Impax closed the regular session unchanged at $20.


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