Cosette Pharmaceuticals obtains FDA OK for generic Rectiv

Cosette has received the Food and Drug Administration’s permission for the first generic version of AbbVie’s Rectiv (nitroglycerin) ointment, 0.4%, with 180 days of Competitive Generic Therapy exclusivity. 

Cosette will imminently commence commercial shipments, triggering the 180-day exclusivity.

Rectiv is used to treat moderate to severe pain caused by chronic anal fissures.

[Read more: Cosette debuts generic Aczone]

"This is a pivotal product approval, and a testament to our unwavering dedication to R&D, operational excellence and innovation,” said Apurva Saraf, president and CEO of Cosette. “This is Cosette’s 24th new product launch and our third CGT approval in the last two years. We look forward to continuing to leverage our solid R&D efforts through our state-of-the-art IVRT/IVPT labs, our manufacturing facility in Lincolnton, N.C., complimented with our business development efforts to continue to deliver high-quality, affordable medications."

Nitroglycerin ointment had a market value of roughly $21.2 million or the 12 months ended January 2024, per IQVIA.