Determination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

r the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. RECTIV (nitroglycerin) ointment, 0.4%, is the subject of NDA 021359, held by AbbVie Inc., and initially approved on June 21, 2011. RECTIV is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. In a letter dated March 27, 2026, AbbVie Inc. notified FDA that RECTIV (nitroglycerin) ointment, 0.4%, was being discontinued, and FDA moved the drug product to the ``Discontinued Drug Product List'' section of the Orange Book. Aurobindo Pharma USA, Inc., submitted a citizen petition dated April 23, 2026 (Docket No. FDA-2026-P-4566), under 21 CFR 10.30, requesting that the Agency determine whether RECTIV (nitroglycerin) ointment, 0.4%, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under Sec. 314.161 that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn for reasons of safety or effectiveness. The p