Opill®, Leqvio®, Dengue Vaccine

New FDA Approvals

In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 10, 2023 – July 14, 2023. Please check back every Monday morning so that you can stay up to date.

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

• Opill® is the first over-the-counter birth control pill approved by the FDA, containing norgestrel tablets as a progestin-only contraceptive. Opill® thickens cervical mucus, prevents the release of eggs, and thins the uterine lining to provide effective contraception. Opill® will be available in stores in the US in early 2024
• Leqvio® (inclisiran) has received FDA approval for expanded use in patients with elevated LDL-C and increased risk of heart disease, in addition to its previous indications. The drug is an RNA therapy that lowers LDL-C levels and is administered via a single subcutaneous injection initially, followed by repeat doses every 3 and 6 months. Clinical studies showed a mean reduction of approximately 50% in LDL-C levels; common adverse reactions are injection site reactions, arthralgia, and bronchitis.
• Takeda has withdrawn its Biologics License Application for the Dengue vaccine candidate, TAK-003, following FDA's request for additional data not included in the application. TAK-003, also known as Qdenga®, is already approved in various countries. Dengue is a mosquito-borne disease causing significant illness and deaths worldwide; currently, there are limited vaccines or other preventive agents available.

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Intro and outro music

Garden Of Love by Pk jazz Collective