The FDA has approved Multaq (dronedarone tablets, from Sanofi-aventis), an antiarrhythmic, to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

The FDA has approved Feraheme (ferumoxytol injection, from AMAG Pharmaceuticals) for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD).

Tri-Lo Sprintec (norgestimate/ethinyl estradiol tablets, from Teva), a generic version of Ortho-McNeil Janssen's oral contraceptive, Ortho Tri-Cyclen Lo, has received FDA approval.

The FDA has approved Tev-Tropin (somatropin [rDNA] for injection, from Teva) for administration by needle-free injection.

Watson Pharmaceuticals has received FDA approval for a generic version of Duramed Pharmaceuticals' Plan B (levonorgestrel tablets) for postpubertal women ≤17 years old.

The FDA has notified healthcare professionals and patients that it has required manufacturers of varenicline (Chantix, from Pfizer) and bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban, from GlaxoSmithKline) to add new Boxed Warnings to the product labeling and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms.

The FDA has notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine [recombinant], from Sanofi-aventis) and a possible risk for cancer in patients with diabetes.

Sucampo reported top-line results from its Phase 2 trial of orally administered cobiprostone for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Pfizer announced the discontinuation of the SUN 1122 Phase 3 trial evaluating Sutent (sunitinib malate) plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI monotherapy for the first-line treatment of metastatic colorectal cancer (CRC).