www.fdanews.com/articles/125156-fda-sets-deadline-for-makers-of-unapproved-narcotic
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
Washington Drug Letter