We have continued to successfully manage our business despite the challenges in our operating environment. Our team has remained dedicated to delivering high-quality medicines for our patients, while also developing new medicines for the future.
We’re pleased to share several notable developments from the first quarter of 2023:
- The FDA granted our request for a waiver and will refund nearly $2 million in fees that we previously provided.
- We also learned that the federal NOPAIN legislation was enacted and expect that our non-opioid injection product Caldolor® (ibuprofen) will qualify for favorable reimbursement.
- Our newest acquisition Sancuso® has now largely been successfully integrated. It’s an FDA-approved prescription patch designed to help cancer patients better tolerate certain chemotherapy treatments.
- In addition, the FDA approved moving Sancuso’s manufacturer to a new facility, which will be our source of future product supplies.
- We are now settled into our new headquarter offices at the Broadwest campus in the Vanderbilt/West End corridor of Nashville. This move will accommodate our growth and better support our team, customers and partners.
During the first quarter, we continued to support our international partners in their efforts to register our brands in their countries. Developments include:
- PiSA Pharmaceutical preparing their submission for distribution of Caldolor in Mexico.
- Tabuk Pharmaceutical updating the approval in Saudi Arabia to introduce Vibativ® into the Middle East.
- SciClone Pharmaceuticals addressing regulatory inquiries, as they seek approval for Vibativ in China.
- DB Pharm Korea Co. Ltd. filing for the approval of Vibativ in South Korea, where they also distribute Caldolor.
As always, I’d like to extend a big thank you to our team at Cumberland for their dedicated efforts in support of our mission – to provide high-quality medicines that improve patient’s quality of life.
We look forward to sharing more updates with you throughout the year.