February 23, 2010
The FDA has notified healthcare professionals and patients that it is reviewing clinical trial data about a potentially serious effect on the heart associated with the use of Invirase (saquinavir, from Roche) in combination with Norvir (ritonavir, from Abbott).
February 16, 2010
The FDA has approved a heat-stable formulation of Norvir tablets (ritonavir, from Abbott) that can be stored at room temperature.
January 29, 2010
The FDA has notified healthcare professionals and patients that the use of Videx or Videx EC (didanosine, from Bristol-Myers Squibb) may cause non-cirrhotic portal hypertension, a rare but serious complication.
January 28, 2010
Tibotec Therapeutics announced that the FDA has approved an updated label for Prezista (darunavir tablets) which includes 96-week data from the ARTEMIS and TITAN studies.
January 26, 2010
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets, and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets due to 'coring,' the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted).