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The Food and Drug Administration (FDA) has approved the first generic version of Rectiv® (nitroglycerin) ointment, 0.4%.
Cosette Pharmaceuticals’ Nitroglycerin Ointment 0.4% is a nitrate vasodilator indicated for the treatment of moderate to severe pain associated with chronic anal fissure. The ointment contains 4mg of nitroglycerin per 1g of ointment and is applied intra-anally.
The product is supplied in a 30g tube and will be available soon, according to the Company.
Nitroglycerin ointment should be avoided in patients who are using phosphodiesterase type 5 inhibitors (eg, sildenafil, vardenafil and tadalafil) as these agents may potentiate the hypotensive effects of organic nitrates. Additionally, the product is contraindicated in patients with severe anemia or in those with increased intracranial pressure.
References:
- Cosette Pharmaceuticals announces the approval and launch of first generic version of Rectiv® (nitroglycerin) ointment, 0.4%, with 180 days competitive generic therapy (CGT) exclusivity. News release. Cosette Pharmaceuticals. February 22, 2024. https://www.businesswire.com/news/home/20240222076554/en/Cosette-Pharmaceuticals-Announces-the-Approval-and-Launch-of-First-Generic-Version-of-RECTIV%C2%AE-nitroglycerin-ointment-0.4-with-180-days-Competitive-Generic-Therapy-CGT-exclusivity.
- Nitroglycerin oOintment 0.4%. Package insert. Cosette; 2023. Accessed February 22, 2024. https://cosettepharma.com/wp-content/uploads/2024/02/Nitroglycerin-Ointment-Package-Insert-1-1.pdf.
