Product news from 05/05/06 News Brief
Cephalon received FDA approval for Nuvigil (armodafinil) tablets for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder. FDA approval of Nuvigil is contingent upon finalizing the product label.
The FDA approved two new higher-dose formulations of Novartis’ high-blood pressure medication Diovan HCT (valsartan/hydrochlorothiazide)—320/12.5 mg and 320/25 mg. The new formulations will be commercially available by early June 2006.
MGI Pharma and SuperGen received FDA approval for Dacogen (decitabine) for injection treatment of patients with myelodysplastic syndromes (MDS). Dacogen is expected to be commercially available during the second quarter of 2006.