Questcor Pharmaceuticals Inc. said Wednesday that the Food and Drug Administration will need more time before it can approve Questcor's Acthar gel as a treatment for infantile spasms.
Acthar has been on the market for decades, and Questcor is seeking a new marketing approval. But the company said it has been told the FDA will need more time and will not be able to make a decision by Saturday as it had expected. It did not say when the FDA might finish the review.
Questcor said the FDA needs time to finalize wording on the drug's label, to review Questcor's proposed medication guide, and to define any post-approval commitments. The labeling for Acthar was last changed in 1978, when the drug was approved to treat flare-ups associated with multiple sclerosis.
The company also said shipments of Acthar in the third quarter are on pace to surpass their total in the second quarter.
In aftermarket trading, Questcor shares lost 56 cents, or 5.4 percent, to $9.82. The stock rose 7.9 percent during the day and closed at $10.38.