The FDA has approved Schering-Plough’s Noxafil (posaconazole) oral suspension for prophylaxis (prevention) of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised. Noxafil is the first and only antifungal agent approved by FDA for the prevention of invasive fungal infections caused by Aspergillus species.
GlaxoSmithKline submitted a New Drug Application to the FDA for approval to market Tykerb (lapatinib ditosylate), in combination with Xeloda (capecitabine), for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in women who have received prior therapy, including Herceptin (trastuzumab). The compound has been granted “fast track” status by the FDA in this patient population.
The European Commission approved Pfizer’s Lyrica (pregabalin capsules) to treat central neuropathic (nerve) pain. The new approval broadens the current range of neuropathic pain that Lyrica is approved to treat in Europe to include nerve pain associated with conditions such as spinal cord injury, stroke, and multiple sclerosis.