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

   www.fda.gov › drugs › drug-approvals-and-databases

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

   • Orange Book Information on Reference Standard

     An outline of data updates to "Approved Drug Products with...

2. www.fda.gov › drugs › development-approval-process-drugsDrug Approvals and Databases | FDA - U.S. Food and Drug...

   www.fda.gov › drugs › development-approval-process-drugs

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   Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Additional topics include: approved REMS, drug shortages, and the...

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

   s3-us-west-2.amazonaws.com › drugbank › cite_this

   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

   www.fda.gov › drugs › drug-approvals-and-databases

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

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

   www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8

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   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 ...

6. www.ema.europa.eu › en › medicinesDownload medicine data | European Medicines Agency (EMA)

   www.ema.europa.eu › en › medicines

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   Download medicines data table. All relevant information and documents on medicines authorised at a European Union (EU) level are available on medicine pages. This includes: Full scientific assessment reports. Public-friendly overviews in question-and-answer format.

7. www.nature.com › articles › nrd1685News Analysis | Nature Reviews Drug Discovery

   www.nature.com › articles › nrd1685

   Two studies in the Journal of the American Medical Association place ximelagatran (Exanta; AstraZeneca) in the spotlight again for the first time since the FDA rejected approval of the...