On January 18, 2019, Cumberland Pharmaceuticals Inc. received notification from the U.S. Food and Drug Administration ("FDA") setting September 2019 as the Prescription Drug User Fee (“PDUFA”) action date for an approval decision regarding the New Drug Application (“NDA”) for itsr methotrexate product line. The company new line of methotrexate products is designed for the treatment of adult and pediatric patients with rheumatoid arthritis, as well as adults with psoriasis. The NDA was accepted for filing by the FDA earlier this month following its submission to the FDA in November 2018. In conjunction with the submission, the company remitted a payment of $1.3 million to the FDA for the PDUFA Application Fee associated with this methotrexate product line NDA.