Generic Bupropion XL Reevaluation Running Behind Schedule
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA has received data from just one of four bioequivalence studies of 300 mg bupropion extended-release generics it requested by March from sponsors following Impax/Teva’s withdrawal of their generic version due to lack of bioequivalence.
You may also be interested in...
Generic Bupropion XL Must Be Retested; Teva/Impax 300 mg Withdrawn After Efficacy Concerns
In what appears to the first downgrade of a generic equivalency based on patient complaints, FDA changes the high dose of the Teva/Impax product from AB to BX. The four other generic manufacturers of 300 mg bupropion extended-release must conduct their own bioequivalence tests, but FDA does not expect problems because they are differently formulated than the Teva/Impax version.
Biden Team To ‘Explore’ Dose-Sparing Strategies For COVID-19 Vaccines, But Details Sparse
New US leadership has a more comprehensive COVID-19 strategy, but that doesn’t mean all the plans are fully fleshed out yet. While Biden team declines to provide any details on what new vaccine dosing strategies they plan to examine, CDC quietly updates its recommendations to allow six weeks between shots.
Medicare Payment Cuts For Vaccines: MedPac Suggests Moving To New WAC-Reimbursement Formula
Proposal, which could be formally endorsed by MedPac this spring, would lower the payment rates for vaccines while simultaneously moving all preventative vaccine coverage to Medicare Part B. Commission signals further cuts to payment rate, through an average sales priced-based methodology that might eventually be recommended.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: