This section of the newsletter discusses recent drug approvals from U.S. Food and Drug Administration (USFDA) for various serious diseases. The section outlines the role of new drugs in the treatment of serious diseases such as cancer, heart disease and use of tobacco products. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
1. US FDA approved Ayvakit for treatment of rare mutation disease1
US FDA had approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to remove with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach or small intestine. Ayvakit is a kinase inhibitor, blocking an enzyme called a-kinase and helps keep the cancer cells from growing. FDA has given the approval to Blueprint Medicines Corporation.
2. US FDA approves first generics of Eliquis2
US FDA had approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. The FDA granted approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc.
3. US FDA finalizes enforcement policy against certain unauthorized flavored e-cigarettes3
USFDA has issued a policy prioritizing enforcement against certain unauthorized flavored, including fruit and mint flavored e-cigarette products that appeal to kids. . The final guidance outlining the agency's enforcement priorities for electronic nicotine delivery systems (ENDS), such as e-cigarettes and e-liquids, came as the 2019 National Youth Tobacco Survey (NYTS). Cartridge-based ENDS products are a type of ENDS product that consists of or involves a cartridge or pod that holds a liquid that is to be aerosolized when the product is used. For purposes of this policy, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an ENDS product.
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