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  1. www.fda.gov › drugs › drug-approvals-and-databasesDrugs@FDA Data Files | FDA - U.S. Food and Drug Administration

    5 Δεκ 2023 · Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

  2. www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee...

    New Drug Application (NDA) 21-686, submitted by AstraZeneca LP (AstraZeneca), requests approval for the use of EXANTA® (ximelagatran) Tablets as: An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute VTE An oral 36-mg bid fixed dose ...

  3. s3-us-west-2.amazonaws.com › drugbank › cite_thisexanta (ximelagatran) tablets nda 21-686 fda advisory committee...

    EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 3 Development of ximelagatran The efficacy and safety of ximelagatran has been studied in a broad range of thrombogenic states in large, worldwide, comparator-controlled, and primarily outcome-based clinical studies.

  4. www.fda.gov › drugs › drug-approvals-and-databasesFDA Adverse Event Reporting System (FAERS) Database

    FDA Adverse Event Reporting System Database supports the FDA's post-marketing safety surveillance program for all marketed drug and therapeutic biologic products.

  5. medicalsciences.stackexchange.com › questions › 24987How to find FDA's and EMA's review reports and related minutes

    The FDA's database on medical devices appears to be compiled here. For drug, following you can find the review reports from here . For example, if you search for the tamiflu, following two are hit.

  6. en.wikipedia.org › wiki › XimelagatranXimelagatran - Wikipedia

    Ximelagatran (Exanta or Exarta, H 376/95) is an anticoagulant that has been investigated extensively as a replacement for warfarin [1] that would overcome the problematic dietary, drug interaction, and monitoring issues associated with warfarin therapy.

  7. jamanetwork.com › journals › jamaXimelagatran—Promises and Concerns - JAMA Network

    9 Φεβ 2005 · Download PDF Full Text. Cite This. Citation. Gurewich V. Ximelagatran—Promises and Concerns. JAMA ... 2022 IAS-USA Recommendations CONSERVE 2021 Guidelines for Reporting Trials Modified for the COVID-19 Pandemic Creation and Adoption of Large Language Models in Medicine Global Burden ... Register for email alerts with links to free full-text ...