Cardiome and Astellas receive approvable letter for Kynapid

Cardiome and Astellas have received an approvable letter from the US FDA for Kynapid (vernakalant hydrochloride) Injection for the treatment of atrial fibrillation. The FDA requires additional information associated with the risk of previously identified events experienced by a subset of patients during the clinical trials in order to assure an acceptable risk benefit profile [...]

UCB receives non approvable letter for lacosamide in diabetic neuropathic pain

UCB has received a not-approvable letter from the U.S. FDA for lacosamide for the treatment of diabetic neuropathic pain in adults.

CV therapeutics announce FDA is continuing review of Ranexa for Angina

CV Therapeutics have announced that the FDA is continuing its review of Ranexa (ranolazine extended-release tablets) even though the PDUFA action date of July 27, 2008 has been met. The drug is under review for first line treatment of chronic angina and a significant reduction in cautionary language, based on substantial data from the MERLIN [...]

Durects Bupivacaine Receives Orphan Drug Designation for Post-Herpetic Neuralgia

Durect have announced that its transdermal bupivacaine product Eladur has received orphan drug designation for the relief of persistent pain associated with post-herpetic neuralgia.

Anesiva Needle-Free Zingo for reducing pain from IV Starts and Blood Draws in Children

Anesiva has launched its Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system for use in  reducing the pain associated with peripheral intravenous line placements and blood draws in children three to 18 years of age.

NeurogesX submit IND for liquid formulation of Capsaicin, NGX-1998

NeurogesX have submitted an IND for the liquid formulation of Capsaicin, NGX-1998 for the treatment of pain