FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT SYNDROS (DRONABINOL) SOLUTION, 5 MILLIGRAMS/MILLILITER, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, July 3 -- Food and Drug Administration has issued a notice called: Determination That SYNDROS (Dronabinol) Solution, 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on July 3 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SYNDROS (dronabinol) solution, 5 mg/mL, if all other legal and regu...