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FDA pipeline preview, November 2007
The 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
Key Points
Approvable designations
• Anecortave depot suspension (Retaane, Alcon) for the treatment of wet age-related macular degeneration
• Lamotrigine extended-release (Lamictal XR, GlaxoSmithKline) for the treatment of epilepsy
• Pramlintide injection (Symlin, Amylin) for use with basal insulin (without mealtime insulin) in patients with type 2 diabetes who have not achieved desired glucose control
• Frovatriptan (Frova, Endo/Vernalis) for the short-term prevention of menstrual migraine
• Lumiracoxib (Prexige, Novartis) for the once-daily treatment of osteoarthritic pain
Fast-track designation
• PI-88 (Progen) for the prevention of tumor recurrence following curative liver resection in patients with hepatocellular carcinoma
Priority review
• C1 inhibitor (Cinryze, Lev) for the acute treatment of hereditary angioedema
• Etravirine (TMC125, Tibotec) in combination with other antiretroviral agents for the treatment of HIV-1 in adult treatment-experienced patients
Orphan drug designations
• IPI-504 (Infinity/MedImmune) for the treatment of gastrointestinal stromal tumors
• Parathyroid hormone (rDNA origin) for injection (Preos, NPS) for the treatment of hypoparathyroidism
• Pafuramidine (DB289, Immtech) for the treatment of human African trypanosomiasis (African sleeping sickness)
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
