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).
September 29, 2009
Acrux announced positive results from its Phase 3 trial of Axiron (testosterone topical solution 2%) for the treatment of testosterone deficiency (hypogonadism).
May 07, 2009
The FDA has announced that it will require a boxed warning to be included on the product labeling for two prescription topical testosterone gel products, AndroGel (testosterone 1%, from Solvay Pharmaceuticals) and Testim (testosterone 1%, from Auxilium Pharmaceuticals).
March 12, 2009
Endo Pharmaceuticals and Indevus Pharmaceuticals have announced that the FDA has accepted for review their complete response submission to the new drug application (NDA) for Nebido (testosterone undecanoate).
September 02, 2010
Abbott announced that the FDA has approved its RealTime HBV assay for measuring the amount of hepatitis B virus (HBV) in human plasma or serum from individuals chronically infected with HBV.