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.
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Children being treated with a short course of oral corticosteroids for an acute asthma attack may experience a brief and transient depression of their immune response, according to a recent study conducted by Université de Montréal.
A recent recall of generic warfarin tablets was expanded to include 6 other drug products prepared on the same packaging line.
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.
Treatment of bipolar disorder: A focus on medication therapy for mania; Focus on ceftaroline; Agents in late-stage development for the treatment of rare cancers
Agents in late-stage development for the treatment of rare cancers.
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.
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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.
Sunitinib and everolimus improved progression-free survival in patients with advanced pancreatic neuroendocrine tumors, according to 2 recent studies.
The rate of decline in the use of atypical antipsychotics in outpatients with dementia accelerated following a black box warning by FDA, according to a multicenter study of national Veterans Affairs data.
Tranexamic acid reduces the risk of death from bleeding without increasing the risk of vascular occlusive events or the need for surgical intervention in patients with acute traumatic injury, according to a review published in the 2011 Cochrane Database of Systematic Reviews.
FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.
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.
Forest Laboratories $1.2 billion acquisition of Clinical Data, the developer of Viibryd (vilazodone HCl) for the treatment of adults with major depressive disorder, is expected to allow Forest to leverage its existing presence in the antidepressant category.
FDA has approved Corifact (CSL Behring), the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
FDA has granted fast-track designation to a novel endothelial cell-based therapy (Vascugel, Pervasis) for the prevention of hemodialysis access failure in patients with end-stage renal disease.
Less than 1 month after the Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices recommended that most Americans aged 60 years and older get vaccinated to prevent herpes zoster, the vaccine (Zostavax, Merck) is on back order.
FDA has announced that the physician labeling and patient medication guide for rosiglitazone (Avandia, GlaxoSmithKline) have been changed to include information on cardiovascular risks (including death) of this agent.
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