Federal Register #FDA2026P4566

FDA Notice: RECTIV (Nitroglycerin) Ointment, 0.4% Market Withdrawal Determination

This notice from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, addresses the market status of RECTIV (nitroglycerin) ointment, 0.4%: - The FDA has determined that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn from sale for reasons of safety or effectiveness - This determination allows continued approval of abbreviated new drug applications (ANDAs) referencing RECTIV, as long as they meet all regulatory requirements - RECTIV (nitroglycerin) ointment, 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure - The product is the subject of NDA 021359, held by AbbVie Inc. - A citizen petition from Aurobindo Pharma USA, Inc. is referenced in the notice - No procurement of products or services is being solicited; this is a regulatory determination, not a purchasing opportunity

Description

The Food and Drug Administration (FDA) has determined that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product. FDA will continue to approve ANDAs referring to this product as long as they meet relevant legal and regulatory requirements. The drug is indicated for the treatment of moderate to severe pain associated with chronic anal fissure and was initially approved on June 21, 2011.

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