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Determination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Detected July 16, 2026 · in Pharmaceutical Manufacturing (FDA/DEA)

FDA determined that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn for safety or effectiveness reasons, meaning ANDA applicants can reference it as a Reference Listed Drug (RLD). This maintains market access for generic versions.

Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 16, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Generic/ANDA manufacturers and branded drug makers of nitroglycerin ointment should confirm how it applies to their specific situation before acting. There is a time constraint attached: None. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.

What changed

FDA confirmed RECTIV remains an RLD, allowing ANDA applicants to rely on its safety/efficacy data for generic approvals.

Who it affects

Generic/ANDA manufacturers and branded drug makers of nitroglycerin ointment

What you must do

No immediate action; monitor for ANDA filings referencing RECTIV.

Deadline

None

Source: https://www.federalregister.gov/documents/2026/06/26/2026-12953/determination-that-rectiv-nitroglycerin-ointment-04-was-not-withdrawn-from-sale-for-reasons-of

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