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    Home > Active Ingredient News > Drugs Articles > In 2019, FDA approval report on generic drugs: 1171 approvals set a record, 125 approvals were the "first batch"

    In 2019, FDA approval report on generic drugs: 1171 approvals set a record, 125 approvals were the "first batch"

    • Last Update: 2019-10-18
    • Source: Internet
    • Author: User
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    On Wednesday (October 16), the U.S FDA released a notice on the approval of generic drugs in fiscal 2019 FDA has been committed to promoting drug competition by increasing generic drugs In fy2019, the number of generic drugs approved reached a new record, with 1171 generic drugs approved, 935 of which were fully approved and 236 of which were provisional approved This is higher than the record of 971 generic approvals in 2018 It is worth noting that 125 of 1171 approvals this year are the "first batch" of generic drugs, which means that there is no generic competition in the original research drug products before The first generic drug used for the emergency treatment of opioid overdose - naloxone hydrochloride nasal spray (narcan) is one of them This is the first generic drug approved by narcan in the United States in 1971, and also the first general naloxone nasal spray that can be used in the community for people without medical training The FDA has also taken unprecedented steps to help pharmaceutical companies obtain the approval of over-the-counter naloxone products, explore other ways to increase the use of naloxone products for the community, and propose whether naloxone should be co prescribed with all or part of opioids to reduce the risk of overdose death In addition to narcan's first imitation, in 2019, FDA approved a variety of drugs for the treatment of pulmonary hypertension, breast cancer, epilepsy, depression and infectious diseases In addition, FDA is also working to approve more and more complex generic drugs, which are difficult to replicate and traditionally lack competition The monthly report on generic drugs in fy19f the US FDA and the federal government encourage the use of generic drugs, saving consumers direct costs and promoting drug competition, thus reducing overall prices Currently, generic drugs account for about 90% of all prescription drug purchases in the United States In 2018, market competition from generic drugs saved healthcare systems about $293 billion "FDA has made unremitting efforts through the drug competition action plan and the user fee amendment of generic drugs, and has established a benign and active generic drug plan Although the number of approvals varies from month to month, the overall data for 2019 shows that generic approval has achieved another success " "It's not enough to bring generic drugs to the market Consumers need to be confident in the safety and quality of generic drugs," said ned Sharpless, acting director of FDA, in the announcement FDA's scientific review and evaluation of generic drug applications ensure that they have the same function, active ingredients and use conditions as the original drugs in human body Once approved, FDA will continue to monitor the safety and effectiveness of generic drugs " Although the FDA is full of achievements in its plan, some scholars do not buy it They believe that "it may be too early to make a conclusion now" According to a study published by Yale University researcher Kuo Jiao and others in JAMA network on October 11, the total number of generic drug applications approved by FDA increased slightly from July 2016 to December 2018, but the approval proportion of drugs "facing limited competition" or "past shortage" remained stable (see the figure below) The study focused on the approval of generic drugs during generic drug shortages, in part to determine whether FDA measures to improve generic competition could have any impact on generic drug shortages The final conclusion is that it does not seem certain about the impact of policy on the market "Disruption in drug supply has become more common due to the lack of older versions of patented drugs in the market and the lack of competitiveness of generic drugs," the US Centre for biosimilars said In addition to causing treatment problems for patients, it is not conducive to medical cost savings " In defining drug competition, FDA classifies two or fewer existing manufacturers approved for generic drugs, or three or more Drug shortage is defined as the shortage of any drug with the same active ingredient and dosage for one month or more within five years after approval The authors of the study said: "although the FDA's efforts to increase generic approval with the risk of 'price spikes and shortages' have not had a significant effect, it is undeniable that new drug applications require time for drug manufacturers to prepare, and then wait another 6-12 months for regulatory review We still need to continue to focus on promoting the approval of generic drugs with "limited competition and past shortages." In fact, three months before the report, Teva, the generics giant, announced that it would stop producing its generic version of vincristine, which is essential for the treatment of childhood cancers, including leukemia, lymphoma and brain tumors Doctors are worried that this will lead to a shortage of the drug In this case, Pfizer recently took over and started to increase the production of vincristine to meet the market demand (for details, Teva discontinued important children's chemotherapy drugs, Pfizer's "rescue site"!) Reference source: [1] FDA announcements record number of generic drug approvals [2] statement on continued progress enhancing patient access to high quality, low-cost generic drugs [3] Pfizer Looks to Fill Void for Chemo Drug After Teva Discontinues Its Generic Version [4] Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration[5] Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance
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