FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT RECTIV (NITROGLYCERIN) OINTMENT, 0.4%, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, June 26 -- Food and Drug Administration has issued a notice called: Determination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on June 26 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Food and Drug Administration (FDA, Agency, or we) has determined that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to appr...