Thursday, February 9, 2012

Impax factory not yet cleared by FDA, may delay some drug approvals

Impax Laboratories Inc. said Thursday that the Food and Drug Administration hasn’t yet inspected a Hayward factory and that approvals of some drugs may be held up as a result.
Hayward-based Impax (NASDAQ: IPXL) got a warning letter from the FDA last year about the way drugs are sampled and tested at the factory.
Although it is still able to use the factory - the FDA didn’t shut it down - the downcheck can affect approval of drugs that list the factory as a manufacturing site.

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