FDA actions in brief, December 2007
December 1st 2007FDA-related information through December 2007 for nilotinib (Tasigna), sitagliptin (Januvia), SymlinPen120, SymlinPen60, terbinafine (Lamisil), diclofenac (Voltaren Gel), sevelamer (Renvela), brimonidine/timolol (Combigan), Zingo, Totect, Menactra, FluMist, ACAM2000, Afluria, palonosetron injection (Aloxi), bortezomib (Velcade), certuximab (Erbitux), alemtuzumab (Campath), fosamprenavir (Lexiva), and tipranavir (Aptivus)
Topotecan: Oral chemotherapy agent approved for the treatment of relapsed SCLC
December 1st 2007This oral formulation of topotecan was approved on October 12, 2007, for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response who are ≥45 days from the end of first-line chemotherapy.
FDA pipeline preview, November 2007
November 1st 2007The latest FDA action (through November 2007) related to anecortave depot suspension (Retaane), lamotrigine extended-release (Lamictal XR), pramlintide injection (Symlin), frovatriptan (Frova), lumiracoxib (Prexige), PI-88, C1 inhibitor (Cinryze), Etravirine, IPI-504, Parathyroid hormone (rDNA origin) for injection (Preos), and pafuramidine