February 08, 2010
Talecris Biotherapeutics was granted orphan drug designation by the FDA for the development of an aerosol formulation of alpha1-proteinease inhibitor to treat congenital alpha1-antitrypsin (AAT) deficiency.
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).
January 15, 2010
The FDA announced that data from a recent review of Spiriva HandiHaler (tiotropium dry powder for inhalation, from Boehringer Ingelheim) do not support an increased risk of stroke, heart attack, or death.
December 21, 2009
Spiriva HandiHaler (tiotropium powder for oral inhalation, from Boehringer Ingelheim and Pfizer) has been approved by the FDA for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
October 19, 2009
The FDA has approved Prolastin-C (alpha1-proteinase inhibitor [human], from Talecris Biotherapeutics), a more concentrated formulation of Prolastin, for the treatment of alpha1-antitrypsin (AAT) deficiency.