FDA has approved crizotinib (Xalkori, Pfizer), the first and only therapy specifically for patients with locally advanced or metastatic non-small-cell lung cancer that is ALK-positive as detected by an FDA-approved test.
FDA has approved tapentadol extended-release tablets (Nucynta ER, Janssen Pharmaceuticals), an oral analgesic taken twice daily, for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
FDA has approved onabotulinumtoxinA (Botox, Allergan) for injection for the treatment of urinary incontinence resulting from detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury [SCI], multiple sclerosis [MS]) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.
An antidote indicated for the treatment of acute cyanide poisoning judged to be life-threatening has launched.
Antibacterial drug use in children is associated with a dose-dependent increased risk of acquiring community-associated methicillin-resistant Staphylococcus aureus (Ca-MRSA), according to the results of a population-based, case-control study reported online August 1 in the Archives of Pediatrics & Adolescent Medicine.
Once-daily oral rivaroxaban (Xarelto, Bayer), a direct factor Xa inhibitor, appears to be as effective as dose-adjusted warfarin in preventing stroke or major embolism in patients with nonvalvular atrial fibrillation, according to a study published online August 10 in the New England Journal of Medicine.
FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics) to treat 2 types of lymphoma.
The Centers for Disease Control and Prevention warned this week that the antimalarial drug primaquine is not available until September, 2011.
FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty.