FDA nod to Eisai’s ONTAK solution
The U.S. Food and Drug Administration has granted full approval to Eisai Corporation’s ONTAK(R) (denileukin diftitox) solution to be used in the form of an intravenous injection for treating patients suffering from recurrent cutaneous T-cell lymphoma (CTCL) . The supplemental biologics license application is based on findings of a Phase III clinical trial that measured the efficacy of ONTAK in patients with this rare form of malignant lymphoma.

The U.S. Food and Drug Administration has granted 510(k) clearance to
The U.S. Food and Drug Adminstation has cleared expanded labeling to
The U.S. Food and Drug Administration has given clearance to Teleflex Medical for launching its Hudson RCI Neb-U-Mask® in the market. The product is a respiratory device used for the treatment of acute asthma exacerbation. It allows for the simultaneous delivery of aerosolized drug and high concentrations of medical gases like oxygen or heliox. Having a patented innovative wye design, the system features a nebulizer connection and MDI adaptor, a non-rebreathing mask with a 750ml gas reservoir bag, and color coded tubing.
The U.S. Food and Drug Administration has approved an immune globulin product called Gamunex for the treating a rare autoimmune disorder, CIDP. It is characterized by progressive muscle weakness and impaired sensory function in the limbs.