Jantoven 3mg tablets recalled due to mislabeling
Upsher-Smith Laboratories announced a nationwide voluntary recall of Jantoven (warfarin sodium) 3mg tablets with an expiration date of September 2012, Lot #284081NDC #0832-1214-00.
Diagnosis & Disease Information
Avandia label updated to include cardiovascular risk warnings
The FDA is notifying the public that the labeling for Avandia (rosiglitazone tablets, from GlaxoSmithKline) has been updated to include information about associated cardiovascular risks.
FDA warns of potential risk of severe liver injury with Multaq
The FDA has notified healthcare professionals and patients about cases of hepatocellular liver injury and hepatic failure, including two cases of acute liver failure leading to transplantation in patients treated with Multaq (dronedarone tablets, from sanofi-aventis).
Phase 2 study of Revascor for the treatment of congestive heart failure (CHF)
Cephalon and Mesoblast Limited announced positive interim results from its ongoing multi-center Phase 2 trial of Revascor for patients with congestive heart failure (CHF).
NDA submitted for rivaroxaban for the treatment of non-valvular atrial fibrillation (AF)
Johnson & Johnson Pharmaceutical Research & Development announced that it has submitted a New Drug Application to the FDA for rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
Issues in Thrombosis Management and Anticoagulation
Novel oral anticoagulants, that do not require the laboratory monitoring associated with warfarin therapy, may alter the landscape of venous thromboembolism treatment and stroke prevention in atrial fibrillation, according to a study presented at the 52nd American Society of Hematology Meeting and Exposition.
Phase 3 study of edoxaban for the treatment of atrial fibrillation (AF)
Daiichi Sankyo announced that it has completed patient enrollment for its Phase 3 study of edoxaban, to prevent the occurrence of strokes and systemic embolic events (SEE) in patients with atrial fibrillation (AF).
Nexterone approved for arrhythmias
Prism Pharmaceuticals announced that Nexterone (amiodarone HCl) Premixed Injection has been approved by the FDA for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.
Phase 2 study update of Mydicar for advanced heart failure
Celladon announced 12 month data from its Phase 2 study of Mydicar for the treatment of advanced heart failure.
Pradaxa 150mg available for stroke risk reduction
Pradaxa (dabigatran etexilate capsules) 150mg, an oral direct thrombin inhibitor, will be made available by Boehringer Ingelheim on November 3, 2010.
