Drug Pipeline

Overall, it would not appear that the new erythropoiesis-stimulating agents for treatment of cytopenia will add substantially to pharmacy budgets. As they are approved by FDA, each medication will need to be reviewed to understand its complete clinical advantage, and the safety profile will need to be completely understood.

New indication: Hydroxyprogesterone caproate injection was approved by FDA in February to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of at least 1 spontaneous preterm birth.

An update on the management of atrial fibrillation issued by a task force consisting of the American College of Cardiology Foundation, the American Heart Association, and the Heart Rhythm Society has incorporated dabigatran into its recommendations.

Despite advancements, treatment of metastatic breast cancer hinges on multifarious factors and numerous unanswered questions about therapy linger. Agents that are highly active in heavily pretreated patients are needed to optimize outcomes in patients with metastatic disease. This article reviews current and novel treatment options for metastatic breast cancer.

FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older.

FDA released a safety communication to update prescribers and patients about the ongoing review of insulin glargine (Lantus) that was initiated in July 2009.

A substantial portion of antiretroviral-naïve patients are infected with transmitted drug-resistant HIV with one or more drug-resistant mutations, and they are much more likely to experience treatment failure, according to research published in The Lancet Infectious Diseases.

Patients with psoriatic arthritis undergoing their first treatment with tumor necrosis factor-? inhibitor showed a high adherence to therapy and a good response, according to a recent Danish study published in Arthritis & Rheumatism.

Many patients, especially those with limited literacy, do not consolidate prescription medication regimens efficiently, which could lead to nonadherence, according to a recent study in the Archives of Internal Medicine.

The angiogenesis inhibitor bevacizumab, used with chemotherapy or biological therapy, carries an increased risk of treatment-related death in cancer patients compared with chemotherapy alone, a new study shows.

FDA has updated the pregnancy section of drug labels for the entire class of antipsychotic medications to provide more information about the potential risk of extrapyramidal signs and withdrawal symptoms in newborns whose mothers take antipsychotics during the third trimester of pregnancy.

FDA's Pulmonary-Allergy Drugs Advisory Committee voted to approve Novartis' QAB149 (indacaterol) 75 µg as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, PR Newswire reported.

FDA approved the first-and-only selective phosphodiesterase type 4 inhibitor roflumilast (Daliresp, Forest Pharmaceuticals), once-daily oral tablet to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease.

FDA approved the use of once-daily guanfacine (Intuniv, Shire) extended-release tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder in children and adolescents aged 6 to 17 years as part of a total treatment program.

FDA issued a complete response letter to EMD Serono, an affiliate of Merck KGaA, requesting additional information on cladribine (Movectro), a drug intended for the treatment of relapsing-remitting multiple sclerosis.

In mid February, US Marshals acting on a request of FDA seized all lots of Auralgan Otic Solution from Integrated Commercialization Solutions in Brooks, Ky.

Recent FDA action (through, February 2011) related to Contrave, rabeprazole sodium extended-release capsules, Avodart, Mu Delta, Carfilzomib, Vascugel, INX-0818, vosaroxin, Acurox, fidaxomicin, melanoma cancer vaccine, NSI-566RSC, Regorafenib.

New formulation: Fentanyl sublingual tablets were approved by FDA to manage breakthrough pain in patients aged ?18 years who are already receiving and tolerant to opioids for their underlying persistent cancer pain.

Generic drugs approved by FDA (through February 2011): Galantamine hydrobromide

The active drug safety surveillance system being established by FDA promises to do more than obtain timely adverse event information on marketed medicines.

New molecular entity: Vilazodone hydrochloride tablets were approved by FDA on January 21, 2011, for the treatment of major depressive disorder in adults.

Recent FDA Approvals (through February 2011) related to Edarbi, Gralise, Rituxan, Menveo, Makena, Corifact, Epicyn HydroGel

In recent years there has been an explosion of new investigations into the pathophysiology of bipolar disorder and its medication therapies. This article will review current, emerging, and controversial therapies for the treatment of bipolar disorder, specifically the mania aspect.

Ceftaroline has demonstrated activity against methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae as well as common respiratory Gram-negatives including Haemophilus, Moraxella, and Klebsiella species.

FDA approved azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceutical North America) to treat hypertension in adults.

Unprecedented levels of drug shortages, especially those drugs for which there are no substitutes, has prompted legislators to take action. Since the inception of the FDA Drug Shortage Program in 2000, the agency has been tracking the nation?s prescription pharmaceuticals and publishing a list of drugs in short supply.

Merck Serono Europe informed the European Medicines Agency that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.

FDA has approved Corifact (CSL Behring), the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

Zinc, in lozenge or syrup form, is beneficial in reducing the duration and severity of the common cold in healthy people, when taken within at least 24 hours of onset of symptoms, according to a new report published in the Cochran Library.