Columbia Laboratories report Phase II results of lidocaine in vaginal dryness

Columbia Laboratories’ vaginally-administered lidocaine has demonstrated efficacy in the treatment of vaginal dryness through dysmenorrhea. although did not meet primary endpoint

Ranolazine Shortens QT Interval and improves Cardiac Relaxation in Patients With Long QT Syndrome

CV Therapeutics have announced results that show ranolazine significantly shortens the QT interval of patients with a hereditary form of long QT syndrome called LQT3. Ranolazine also shortened cardiac relaxation time in the study.

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 [...]

Banner Pharmacaps soft gel Valproic acid approved by FDA

Banner Pharmacaps have announced the US FDA approval of its soft gel Valproic acid for the treatment of manic episodes associated with bipolar disorder

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.

FDA Approves First Generic Divalproex Sodium

The US FDA has approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote for the treatment of seizures, bipolar disorder and migraine headaches.

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 [...]

Phase IIb results show Vernakalant effective in atrial fibrillation

Cardiome Pharma’s Sodium channel antagonist vernakalant  has demonstrated efficacy in a Phase IIb trial for atrial fibrillation.

Ranolazine receives EU marketing authorization for Chronic Angina

CV Therapeutics have announced that the EMEA has granted approval for ranolazine in the treatment of patients with chronic angina in all 27 European Union (EU) member states.

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.