FDA Clears Path for Generic Rectiv Ointment
Published Date: 6/26/2026
Notice
Summary
The FDA has decided that RECTIV (nitroglycerin) ointment, 0.4%, wasn’t taken off the market because of safety or effectiveness problems. This means generic versions can keep getting approved as long as they follow the rules, so patients and pharmacies won’t face shortages or price spikes. If you’re a drug maker or user, this is good news for steady access and affordable options.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Generic Approvals May Continue
The FDA determined on publication June 26, 2026 that RECTIV (nitroglycerin) ointment, 0.4% was not withdrawn for reasons of safety or effectiveness. Because of that determination, FDA will not begin procedures to withdraw approval of approved abbreviated new drug applications (ANDAs) that refer to RECTIV, and additional ANDAs may be approved if they meet legal and regulatory requirements.
Product Remains on Discontinued List
FDA will continue to list RECTIV (nitroglycerin) ointment, 0.4% in the Orange Book's "Discontinued Drug Product List," indicating the product is discontinued from marketing for reasons other than safety or effectiveness. AbbVie notified FDA of the discontinuation on March 27, 2026; the NDA was initially approved on June 21, 2011.
Labeling Updates May Be Requested
If FDA determines that labeling for RECTIV should be revised to meet current standards, the Agency will advise ANDA applicants to submit updated labeling. Aurobindo Pharma USA submitted a citizen petition on April 23, 2026, prompting this determination.
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