Search Results for keywords:"Baxter Healthcare"

Found 2 results

Search Results: keywords:"Baxter Healthcare"

💰 Only
Oldest Newest
  • 2024-31307 — Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
    Type:Notice
    Citation:89 FR 106522
    Reading Time:about 3 minutes

    The Food and Drug Administration (FDA) announced a correction to a previous notice regarding the withdrawal of approval for 23 abbreviated new drug applications (ANDAs). These applications, held by companies like Fosun Pharma USA Inc., Baxter Healthcare Corp., Celltrion USA, and i3 Pharmaceuticals, were initially set to be withdrawn by August 28, 2024. However, because these companies asked in time not to have their ANDAs withdrawn, the approvals remain valid. This notice clarifies the error and ensures the continued approval of these drug applications.

    Simple Explanation

    The FDA accidentally said some medicine approvals were taken away, but actually, they're not. The companies that make these medicines asked not to lose their approval, and the FDA fixed the mistake and said, "Oops, you're still good to go!"

  • 2021-03429 — Authorizations of Emergency Use of Certain Drug and Biological Products During the COVID-19 Pandemic; Availability
    Type:Notice
    Citation:86 FR 10290
    Reading Time:about 10 minutes

    The Food and Drug Administration (FDA) has issued five Emergency Use Authorizations (EUAs) for drugs and biological products during the COVID-19 pandemic. These authorizations, allowed under the Federal Food, Drug, and Cosmetic Act, aim to help address public health emergencies by making medical products available when there are no adequate alternatives. The products authorized include those requested by Baxter Healthcare, the U.S. Department of Health and Human Services, Eli Lilly and Company, and Regeneron Pharmaceuticals. The FDA ensures that these authorizations are based on scientific evidence indicating that the benefits of using these products outweigh the risks.

    Simple Explanation

    The FDA is letting some special medicines be used in emergencies because of COVID-19. These medicines help people when no other options are available, and were given the okay because they're believed to be more helpful than harmful.