On December 6, 2022, Cumberland Pharmaceuticals Inc. received notification from Kyowa Kirin Inc. that the U.S. Food and Drug Administration approved a supplemental new drug application associated with a new site at Kindeva Drug Delivery L.P., for the manufacturing and primary packaging of Cumberland's Sancuso brand. In January 2022, Cumberland acquired the U.S. rights to Sancuso from Kyowa Kirin and assumed full commercial responsibility for the product in the U.S. – including its marketing, promotion, distribution, manufacturing and medical support activities. In March 2019, Kyowa Kirin submitted a Prior Approval sNDA for the new Kindeva manufacturing site.

In June 2019, Kyowa Kirin received a complete response letter from the FDA regarding the sNDA submission which included a request for clinical information. On August 12, 2022, Kyowa Kirin submitted an amendment to the sNDA that included the requested information. After the amendment was reviewed by the FDA, approval was granted.

Based on the terms of the Sancuso acquisition agreement, Cumberland will provide a $1 million milestone payment to Kyowa Kirin who was responsible for developing the needed clinical and manufacturing data, preparing the submission and securing the FDA approval. Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment. The active drug in Sancuso, granisetron, slowly dissolves in the thin layer of adhesive that sticks to the patient's skin and is released into their bloodstream over several days, working continuously to prevent chemotherapy-induced nausea and vomiting.