Approvals

 
 
  • FDA Approves Wider Rosuvastatin Label The FDA's decision was announced late Monday.
  • Transcatheter Valve for RVOT Anomalies of the right ventricular outflow tract require surgical intervention, but the percutaneous valve implant allows patients to undergo a less invasive procedure, delaying the need for further open-heart surgery, according to the agency.
  • Heartmate II Approval FDA approves Thoratec's HeartMate II continuous-flow left ventricular assist device for severe heart-failure patients who are not eligible for a heart transplant.
  • Pediatric Familial Hypercholesterolemia Indication for Crestor The FDA has approved rosuvastatin for use in children aged 10 to 17 years old with familial hypercholesterolemia.
  • New Telmisartan Indication The drug can now be used to reduce the risk of MI, stroke, or death from cardiovascular causes in patients 55 years of age or older who are intolerant to ACE inhibitors but at high risk for cardiovascular events.
  • Prasugrel Approved for Use During PCI, FDA Announces The new antiplatelet, a competitor to its thienopyridine cousin clopidogrel, will be marketed as Effient.
  • FDA Approves Taxus Liberte; Atom DES The FDA has given Boston Scientific the marketing go-ahead for its Taxus Liberté Atom coronary stent system for use in vessels as narrow as 2.25 mm in diameter, according to a company statement.