The Official Medicare Set Aside Blog And Information Resource

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

COVID-19: Impact on the FDA Pipeline

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on April 15, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

The impact of COVID-19 has undoubtedly been profound, but some of its effects are less obvious than others. One of the impacts associated with the COVID-19 pandemic that may not have hit home yet for many is the likely effect on the pipeline of new drug approvals through the FDA. The pandemic will likely produce […] Continue

FDA Grants OTC Status to Voltaren® 1% Gel

FDA, Medicare Set-Aside Blog, Medicare Set-Asides, Rx/Pharmacy on February 21, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Last Friday, while many of us may have been focused on Valentine’s Day activities, the Food and Drug Administration (FDA) was busy granting over-the-counter status to three products which were previously available only by prescription. One of those products was Voltaren (diclofenac) 1% gel, which is manufactured by GSK. When the product makes its OTC […] Continue

FDA Approves Generic Versions of Lyrica

FDA, Medicare Set-Asides, Rx/Pharmacy on July 24, 2019
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

On Monday, the FDA issued a press release announcing the approval of generic versions of the drug Lyrica (pregabalin). Those of us operating in the workers compensation industry are all too familiar with Lyrica. It’s a high-priced medication utilized for the treatment of pain related to nerve damage, and its inclusion within Workers’ Compensation Medicare […] Continue

FDA Grants Approval for Generic Narcan (naloxone HCL) Nasal Spray

FDA, Opioids, Rx/Pharmacy on May 6, 2019
Posted by Jean S. Goldstein, JD, CMSP

Recently, the FDA approved the first generic Narcan nasal spray to treat opioid overdose.  Narcan temporarily reverses the effects of opioid analgesics and is essentially an antidote for opioid overdose.  While generics of the injectable version of this medication, Evzio, have been available for quite some time, a generic of the nasal spray has not.  […] Continue