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[{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Boehringer Ingelheim Gets Positive CHMP Opinion for Use of Pradaxa\u00ae to Treat venous thromboembolic events in Newsborns and Adults","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Alembic Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alembic Pharmaceuticals announces USFDA Tentative Approval for Dabigatran Etexilate Capsules, 150 mg.","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Breckenridge Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Breckenridge Announces Tentative Approval of its ANDA for Dabigatran Etexilate Capsules (generic for Pradaxa\u00ae)","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Dabigatran Etexilate Mesylate
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Details:
Dabigatran Etexilate Capsules (generic for Pradaxa®), is good at preventing blood clots that can cause a stroke or heart attack, but it can be very expensive and must be used carefully in patients with kidney problems.
Lead Product(s):
Dabigatran Etexilate Mesylate
Therapeutic Area: Cardiology/Vascular Diseases
Product Name: Dabigatran Etexilate-Generic
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 22, 2022
Details:
Dabigatran etexilate reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days
Lead Product(s):
Dabigatran Etexilate Mesylate
Therapeutic Area: Neurology
Product Name: Pradaxa
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 23, 2021
Details:
Positive opinion is based on a dedicated clinical pediatric program for dabigatran, including the DIVERSITY study,2 which supplements dabigatran's established and well-documented safety and efficacy profile in adults
Lead Product(s):
Dabigatran Etexilate Mesylate
Therapeutic Area: Cardiology/Vascular Diseases
Product Name: Pradaxa
Highest Development Status: Phase II/ Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 16, 2020