Showing posts with label Acthar Gel. Show all posts
Showing posts with label Acthar Gel. Show all posts

9/6/10

FDA Alert Questcor Pharma

FDA Decision Alert: Questcor Pharma

QCOR: Google Finance Profile

(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.