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This document reviews the clinical pharmacology and biopharmaceutics of dabigatran etexilate, an oral direct thrombin inhibitor, submitted for the approval of prevention of stroke and systemic embolism
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How to fill out Clinical Pharmacology Review NDA 22-512, Dabigatran

01
Begin by gathering all relevant clinical study data related to Dabigatran.
02
Review existing literature and FDA guidelines on clinical pharmacology submissions.
03
Discuss the pharmacokinetics (absorption, distribution, metabolism, excretion) of Dabigatran in various populations.
04
Include data on drug-drug interactions and their clinical significance.
05
Prepare tables and figures to summarize pharmacological data and findings clearly.
06
Write a comprehensive discussion section interpreting the results and their implications for clinical use.
07
Ensure that all sections comply with the FDA's format requirements for NDA submissions.
08
Conduct a thorough review of the submission for consistency and completeness before filing.

Who needs Clinical Pharmacology Review NDA 22-512, Dabigatran?

01
Healthcare professionals involved in prescribing Dabigatran.
02
Regulatory agencies evaluating the drug for approval.
03
Researchers conducting studies involving Dabigatran.
04
Pharmacologists assessing the drug's effects and safety profile.
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Litigation has centred on Boehringer's perceived failure to disclose all the data from post-approval trials. This includes data that showed the number of people who died from bleeding was less than expected, ing to internal documents made public in lawsuits over the product.
At this time, FDA believes the benefits of Pradaxa continue to exceed the potential risks when the drug is used appropriately following the approved drug label. FDA recommends that healthcare professionals continue to prescribe Pradaxa following the recommendations in the drug label.
(f) As an anticoagulant, dabigatran, may increase the risk of myocardial infarction or acute coronary syndrome. Clinicians should consider the possibility of these severe, harmful cardiovascular effects following use of dabigatran.
Do not mix the pellets with any other food or liquid, such as milk or foods containing milk. It is unknown if drinking alcohol will affect dabigatran, but both dabigatran and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.
A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin.
They need to know if you have any of these conditions: bleeding disorders. antiphospholipid antibody syndrome. history of stomach bleeding. mechanical heart valve. kidney disease. recent or planned spinal or epidural procedure. an allergic reaction to dabigatran, other medicines, foods, dyes, or preservatives.
Pradaxa® (dabigatran etexilate) is a prescription medicine that is used to: reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem.

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Clinical Pharmacology Review NDA 22-512 pertains to the evaluation of Dabigatran, an oral anticoagulant used for the prevention and treatment of thromboembolic disorders. It assesses the drug's pharmacokinetics, pharmacodynamics, and overall therapeutic efficacy and safety.
Pharmaceutical companies that develop and seek approval for Dabigatran are required to file the Clinical Pharmacology Review NDA 22-512 as part of their new drug application to the FDA.
To fill out Clinical Pharmacology Review NDA 22-512, applicants must provide comprehensive data on Dabigatran's pharmacokinetics, pharmacodynamics, clinical trial results, and any supporting studies that assess its safety and efficacy.
The purpose of Clinical Pharmacology Review NDA 22-512 is to evaluate the safety and effectiveness of Dabigatran and ensure that it meets regulatory standards for approval prior to marketing.
Information required includes pharmacokinetic data, pharmacodynamic responses, trial results on safety and efficacy, dosing information, and any observed adverse effects associated with Dabigatran.
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Relevant keywords

dabigatran NDA 22-512 clinical pharmacology thrombin inhibitor atrial fibrillation stroke prevention biopharmaceutics Boehringer Ingelheim drug interaction clinical trials

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