Executive Summary Information
|Mechanisms||Competitive inhibition of the BSEP bile salt export pump. Toxicity is attributed to the parent drug, and there is no evidence for formation of reactive metabolites.|
|Comments||Bosentan is selected to exemplify induction of cholestasis without accompanying chemical reactivity or other promiscuous activity.|
|Feedback Contact||Gold Compound Working Group (GCWG)|
|Target||endothelin receptor antagonist|
FDA and Label Information
The following link will display all of the currently approved FDA drug products on the market. The web page will contain a table listing all current products by their respective Tradenames and primary active ingredients. The list is navigable by simply clicking on the product of interest, which will in turn list all of the NDA's and ANDA's associated with that product. From here users can click on a specific NDA or ANDA and see documents that have been submitted for the product that the FDA has made available via their website. The types of documents include approval history, letters, reviews and labels.
FDA Approved Products
This next url will perform a search in the FDA's system for all labels for products that contain Bosentan as an active ingredient.
FDA Label Search
Since every unique drug product receives a separate label, we have included a link to another resource for a specific Acetaminophen product (ACETAMINOPHEN liquid - by Goldline Laboratories, Inc.) which displays the drug label information.
Bosentan tablets label
The following resource link will perform a PubMed query for the terms "bosentan" and "liver toxicity".
The recommended source is Sequoia Research Products Ltd, product number SRP02325b.
|Source||Sequoia Research Products Ltd|
|Quantity||10 mg; 100 mg; 500 mg; 1 g|
|Cost||100 €; 150 €; 450 €; 600 € plus 32 € shipping|
|Storage||Store in original container in a cool dark place.|