The Official Medicare Set Aside Blog And Information Resource

FDA Requires Stronger Warnings for Benzodiazepines   

FDA, Medicare Set-Aside Blog on October 22, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

On September 23, 2020, the FDA Drug Safety Commission announced that manufacturers of benzodiazepines will be required to update the boxed warning within the prescribing information for these products. Benzodiazepines, a group of medications that includes Ativan (lorazepam), Xanax (alprazolam) and others, are commonly used to treat anxiety disorders, panic disorder, insomnia, certain types of […] Continue

FDA Approves New Indication for Spravato (Esketamine) Nasal Spray

FDA, Medicare Set-Aside Blog on October 9, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Last month, the FDA approved a new indication for Spravato (esketamine) nasal spray. Spravato, in combination with an oral antidepressant, is now approved to treat adults with major depressive disorder (MDD) who are experiencing suicidal thoughts or ideation. In granting approval for the new indication, the FDA relied on the results of two phase III […] Continue

FDA Approves Non-Opioid Analgesic for Mild to Moderate Pain

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on August 3, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

On July 16th, the FDA approved Orphengesic Forte, a non-opioid combination analgesic for the treatment of mild to moderate pain associated with acute musculoskeletal conditions. The FDA’s approval came earlier than expected, which many have viewed as a reinforcement of the FDA’s commitment to do everything in its power to combat the opioid epidemic. Orphengesic […] Continue

FDA Issues Draft Guidance on Clinical Research with Cannabis and Cannabis-Derived Compounds

FDA, Medical Cannabis, Medicare Set-Aside Blog on July 28, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Medical cannabis continues to create a host of questions as related to workers’ compensation claims, including the legality of use, particularly as guidance and policies continue to be issued.  On July 21st, the FDA issued draft guidance for clinical research with cannabis and cannabis-derived compounds. The guidance does not apply to fully synthetic versions of cannabis, which […] Continue

FDA Approves First Ibuprofen-Acetaminophen Combination Product

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on May 5, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

The FDA has approved the first ibuprofen-acetaminophen combination product, which will be available as an over-the-counter product and marketed under the name of Advil Dual Action. The use of Advil Dual Action is approved for the temporary relief of minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches and minor pain […] Continue