FDA Sets Deadline for Makers of Unapproved Narcotic

March 9, 2010
The FDA has informed six generic-drug makers that they will face enforcement action after July 24 unless they stop shipping an unapproved morphine sulfate oral solution or submit a supplemental NDA for the product. The enforcement date is based on the Jan. 25 approval of a supplemental NDA for a generic version from Roxane Laboratories. The FDA had informed the drugmakers last April they would have 180 days, after any of them received approval, to stop shipment or submit a supplemental NDA.
Washington Drug Letter