Ulesfia (benzyl alcohol lotion, from Sciele Pharma) has been made available for the topical treatment of head lice infestation in patients ≥6 months of age.

The FDA has approved Watson's over-the-counter nicotine polacrilex gum in coated fruit and cinnamon flavors, the generic equivalent of GlaxoSmithKline Consumer Healthcare's smoking cessation aid, Nicorette Fruit Chill and Cinnamon Surge Coated gums.

Solvay Pharmaceuticals has made available Creon (pancrelipase) delayed-release capsules, a "zero-overfill" pancreatic enzyme product that targets 100% of the lipase amount indicated on the product labeling.

Asacol HD (mesalamine delayed-release tablets, from Procter & Gamble) has been made available for the treatment of moderately active ulcerative colitis (UC).

The FDA has approved Alimta (pemetrexed injection, from Eli Lilly) as maintenance therapy for patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

The FDA has notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses.

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.

Amylin Pharmaceuticals, Eli Lilly and Company, and Alkermes, Inc. announced that the FDA has accepted for review the New Drug Application (NDA) submitted for once-weekly exenatide as a subcutaneous injectable treatment of type 2 diabetes.

Amgen announced that its Phase 3 trial comparing denosumab to Zometa (zoledronic acid, from Novartis) in the treatment of bone metastases in patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa.