Home » FDA Sets Deadline for Makers of Unapproved Narcotic
FDA Sets Deadline for Makers of Unapproved Narcotic
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
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