FDA Approves Generic Form of Sucralfate

The approval for the first generic sucralfate oral suspension is 1 of the 15 complex products the manufacturer expects to launch over an 18- to 24-month period.

The FDA has approved an Abbreviated New Drug Application for a generic version of sucralfate (Carafate, Amneal Pharmaceuticals) oral suspension, 1 g/10 ml. Amneal has immediately initiated commercialization activities, the company said in a press release.

“We are proud to announce our approval for the first generic sucralfate oral suspension, 1 of the 15 complex products we expect to launch over an 18 to 24-month period,” said Chirag and Chintu Patel, co-CEOs, in a press release. “We remain excited about the additional, high-value opportunities in our pipeline and are committed to delivering affordable generic products to our patients. With a diverse and strong generics and specialty portfolio, along with our commitment to operational excellence, we expect to return to growth and drive meaningful value for stakeholders in 2020 and beyond.”

According to the press release, US market annual sales for the 12 months ended October 31, 2019, for sucralfate oral suspension was estimated to be approximately $285 million.

Reference

  • Amneal Announces the Approval and Launch of Generic Carafate [press release]. Bridgewater, NJ. Published December 3, 2019. https://www.businesswire.com/news/home/20191203005302/en/Amneal-Announces-Approval-Launch-Generic-Carafate%C2%AE. Accessed December 4, 2019.