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An FDA panel has recommended that the agency approve Orexigen Therapeutics? and Takeda?s obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.

FDA voted today against approving 2 drugs for the prevention of prostate cancer: finasteride (Proscar, Merck) and dutasteride (Avodart, GlaxoSmithKline).

In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recall of Tylenol Cold Multi-Symptom liquid products; Children?s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors; Junior Strength Motrin Caplets, 24 count; and Rolaids Extra Strength Softchews, Cherry Flavor 36-count package.

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 their propoxyphene-containing products 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.

The National Community Pharmacists Association installed Robert Greenwood of Iowa as its new president during the organization?s 112th Annual Convention and Trade Exposition, held in October in Philadelphia.

A team of pharmacy students from Washington State University?s College of Pharmacy won the 2010 Good Neighbor Pharmacy National Community Pharmacists Association Pruitt-Schutte Student Business Plan Competition. The announcement was made during NCPA?s 112th Annual Convention and Trade Exposition in October in Philadelphia.

The National Association of State Controlled Substances Authorities (NASCSA) has received a $200,000 grant from Purdue Pharma LP, which it will distribute to state government agencies that are able to accept private funding specifically for their state prescription-monitoring programs. NASCSA will manage the solicitation, review, and funding of the grant proposals. Selection of recipients will be based on an independent review conducted by its Special Projects Committee, which consists of association members with expertise in the fields of prescription drug abuse and diversion, and prescription drug-monitoring programs. NASCSA expects to distribute the grants by the end of 2011. The grant is part of Purdue Pharma?s efforts to support the operation, expansion, and awareness of appropriately designed state prescription drug-monitoring programs.

McNeil Consumer Healthcare, a unit of Johnson & Johnson, is voluntarily recalling nearly 128,000 bottles of Tylenol 8-hour caplets after some consumers complained of a musty or moldy odor in the products, the company announced.

In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter.

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 is asking the manufacturers of gonadotropin-releasing hormone agonists to add new safety information to the Warnings and Precautions section of the drugs? labels about an increased risk of diabetes and certain cardiovascular diseases.

New safety information has been added to the label for the HIV antiviral drug saquinavir (Invirase, Genentech), describing potentially life-threatening side effects on heart function when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, FDA announced.

FDA is requiring a labeling change and Medication Guide to warn patients and healthcare providers about the possible risk of atypical thigh-bone (femoral) fracture in patients who take bisphosphonates for the prevention and treatment of osteoporosis.

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 October 11 in Neurology and reported by HealthDay News.

Older cancer patients who receive intravenous bisphosphonate therapy may be at a modestly increased risk for atrial fibrillation (AF), supraventricular tachycardia (SVT), and stroke, according to research published online October 12 in the Journal of Clinical Oncology, HealthDay News reported.

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.

In patients with chronic knee pain due to osteoarthritis, 60 mg to 120 mg of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor (SNRI), administered daily, was found to provide both significant pain control and improve physical functioning.

FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine. To prevent chronic migraine, onabotulinumtoxinA is injected about every 12 weeks in multiple sites around the head and neck to try to dull future headache symptoms.

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.

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.

Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation.

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., will launch its new APP Drug Hotline on Wednesday, November 10, 2010.

An updated consensus statement on the management of hypertension among African Americans places significant emphasis on a comprehensive assessment and appropriate risk stratification of individual patients with hypertension, stated a report published online October 4 in Hypertension, HealthDay News reported.

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.

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.

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.

Pharmacists speak out about choosing the right antibiotic, prescription drug abuse, and generic acquisition costs.

Lack of patient awareness coupled with ballooning numbers of diabetes cases across the United States have impelled pharmacies and organization to make diabetes care and education a priority.