The Official Medicare Set Aside Blog And Information Resource

FDA Approves Esketamine Nasal Spray (Spravato™) for Treatment-Resistant Depression

FDA, MSAs, Rx/Pharmacy on March 13, 2019
Posted by Leah King, PharmD, JD, Pharmacy Consultant

Earlier this month, the Food and Drug Administration (FDA) approved esketamine nasal spray, which will be marketed by Johnson & Johnson (J&J) under the trade name of Spravato™. Spravato is approved for use in conjunction with an oral antidepressant for treatment-resistant depression. The term “treatment-resistant” refers to those patients who have failed to achieve relief […] Continue

Osteoarthritis Drug Receives Fast Track Designation from FDA

FDA, MSAs, Rx/Pharmacy on February 21, 2019
Posted by Leah King, PharmD, JD and Marilyn J. Larrimer, RN, BSN, JD

In late November 2018, the FDA announced that it was granting Fast Track designation to an investigational drug for the treatment of osteoarthritis (OA). The drug, developed by Galapagos, is known by its identifier GLPG1972/S201086.  This drug is one to watch, since it has a novel mechanism of action for this therapeutic category. GLPG1972/S201086 is […] Continue