Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing products containing propoxyphene from the market as well.
FDA has approved denosumab (Xgeva, Amgen), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6-month priority review by FDA. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.
FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.
FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine.
With single-pill, fixed-dose combinations of antihypertensive agents, as well as triple-therapy, single-pill agents emerging, updated guidance on specific types of combination therapy for hypertension has emerged.
FDA has issued a complete response letter for lorcaserin?s (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese?or patients who are overweight?and have at least 1 weight-related co-morbid condition.
Older cancer patients who receive intravenous bisphosphonate therapy may be at a modestly increased risk for atrial fibrillation, supraventricular tachycardia, and stroke, according to research published online Oct. 12, 2010 in the Journal of Clinical Oncology, as HealthDay News reported.
For women with epilepsy, the risk of infertility increases with each additional antiepileptic drug, and more than one-third may be unable to conceive, according to research published online Oct. 11, 2010 in Neurology, HealthDay News reported.
New safety information has been added to the label for the HIV antiviral drug saquinavir mesylate (Invirase, Genentech), describing potentially life-threatening side effects on the heart when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, according to FDA.
FDA is asking the manufacturers of gonadotropin-releasing hormone agonists to add new safety information to the Warnings and Precautions section of the drugs? labels.
In the beginning of September, FDA released a safety announcement reminding healthcare providers of an increased mortality risk associated with the use of the intravenous antibiotic tigecycline (Tygacil) compared to that of other drugs used to treat similar serious infections.
FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine.
FDA has cleared duloxetine hydrochloride (Cymbalta, Eli Lilly and Co.) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain, giving patients with such conditions another treatment option.
On October 20, 2010, FDA approved trastuzumab (Herceptin, Genentech) for use in combination with cisplatin and capecitabine or 5-fluorouracil to treat patients with human epidermal growth factor receptor 2-overexpressing metastatic gastric or gastroesophageal junction cancer who have not received prior treatment for metastatic disease.
FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to severe-pain with adjunctive opioid analgesics, and the reduction of fever.
Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation. It is the first replacement for warfarin to win FDA approval. Warfarin was approved in 1954.
With single-pill, fixed-dose combinations of antihypertensive agents, as well as triple-therapy, single-pill agents emerging, updated guidance on specific types of combination therapy for hypertension has emerged.
New study results show that patients treated with olmesartan medoxomil (Benicar) 40 mg once daily experienced significantly greater blood pressure reductions and higher goal attainment rates than patients treated with losartan potassium (Cozaar) 100 mg once daily, after 8 weeks.
An updated consensus statement on the management of hypertension among blacks places a major emphasis on a comprehensive assessment and appropriate risk stratification of individual patients with hypertension, according to a report published online Oct. 4, 2010 in Hypertension, HealthDay News reported.
A collaborative effort between physicians and pharmacists appears to result in improved blood pressure control in hypertensive patients, and continued education in smoking cessation counseling may help physicians, according to two articles published Oct. 11, 2010 in the Archives of Internal Medicine, HealthDay News reported.
A collaborative effort between physicians and pharmacists appears to result in improved blood pressure control in hypertensive patients, and continued education in smoking cessation counseling may help physicians, according to two articles published Oct. 11, 2010 in the Archives of Internal Medicine, HealthDay News reported.
According to the findings of the DECISIONS survey study published in a September/October supplement of Medical Decision Making, Americans frequently find themselves faced with high blood pressure, high cholesterol, and depression medication decisions that they are ill-prepared to make.
When it comes to pediatric therapy, children ?are not just small adults.? This was one of the dominant messages emerging from the recent National Institutes of Health, Division of AIDS, Forum to Promote TRIUMPH ? TB Research in Underserved Maternal and Pediatric Populations with HIV.
In patients with chronic knee pain due to osteoarthritis, 60 mg to 120 mg of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor, administered daily, was found to provide both significant pain control and improve physical functioning.
In a new randomized, placebo-controlled clinical trial published in the October 13, 2010 Journal of the American Medical Association, trial investigators demonstrated that the use of buprenorphine implants (Probuphine, Titan Pharmaceuticals) could reduce opioid use over a 24-week study period.
