Questcor: FDA Delays Drug Approval

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Questcor: FDA Delays Drug Approval

Questcor announced late Wednesday that the U.S. Food and Drug Administration has delayed for the second time an approval decision for the company's drug Acthar as a treatment for infantile spasms.

A new approval date has not been announced but Questcor said FDA's review will extend beyond the current Sept. 11 deadline because regulators need more time to finalize the wording on the label, review the proposed medication guide, and define post-approval commitments, if any, for the infantile spasms indication.

FDA Alert Questcor Pharma

FDA Decision Alert: Questcor Pharma

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(RTTNews) - In less than a week, the Food and Drug Administration will take a final decision on Questcor Pharmaceuticals Inc.'s (QCOR) H.P. Acthar Gel for the proposed expanded indication of infantile spasms.

The regulatory agency was originally scheduled to rule on Acthar's expanded indication in June. But the deadline was extended in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor.

FDA Advisory Panels Recommends Fewer Drugs This Year

Image via Wikipedia It has been a rough year for Drug Candidates this year. Time after time FDA panels are rejecting more qualified drug approvals. So what really is going on here. Are drug up for FDA approval less safe, less effective, or are the panels more cautious on approvals. These panels have had a devastating effect on the company's stock after these No recommendations. Let's take a closer look into what's really going on.

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