Leqembi, Aveir Pacemaker, Cyclophosphamide Liquid, IPX203

New FDA Approvals

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Get our free download! Implementing AMA Style – 8 Things to Get Right Here are the highlights of this week's episode:

· The FDA granted traditional approval to Leqembi, an Alzheimer's treatment manufactured by Eisai and Biogen. The approval, based on phase 3 data demonstrating reduced cognitive decline in early Alzheimer's patients, makes Leqembi the first approved drug in its class, offering new treatment possibilities for the 6.5 million Alzheimer's patients in the US.

· Abbott's Aveir™ DR Dual Chamber Leadless Pacemaker is the first dual chamber leadless pacemaker system for individuals with abnormal or slow heart rhythms. Utilizing the body's natural conductive properties, the device offers more efficient battery usage compared to other communication technologies and reduces the risk of complications associated with traditional pacemakers due to its minimally invasive implantation procedure.

· The FDA approved a liquid formulation of the cancer drug cyclophosphamide. The new formulation, manufactured by Nevakar, is available in two doses and offers advantages over current powdered forms, including increased stability and reduced risk of dosing errors.

· Amneal Pharmaceuticals received a Complete Response Letter from the FDA regarding IPX203 for Parkinson's disease. While this extended-release formation of carbidopa/levodopa shows promise with more effective therapeutic benefits than current formulations, the FDA requested additional safety information on a component of the drug, carbidopa. Amneal will continue working with the FDA to address its concerns.

Please check back every Monday morning for last week's approvals so that you can stay up to date.

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