Tenecteplase Product Approval Information - Licensing Action

Proper name: Tenecteplase
Tradename: TNKase
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: Reduction of mortality associated with acute myocardial infarction (AMI)
Approval Date: 6/2/2000
Type of submission: Biologics license application

Approval Letter (PDF)

Label (PDF)

Reviews
      Statistical Review - (PDF)
      Clinical Pharmacology and Toxicology Review - (PDF)
      Clinical Review - (PDF)