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)
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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