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.
The Advisory Committee on Immunization Practices announces several changes to the recommended adult immunization schedule for 2011.
An analysis of data from more than 90,000 Medicare managed care enrollees who received care for rheumatoid arthritis found that more than one-third did not receive the recommended treatment with a disease-modifying antirheumatic drug, and that receipt varied by demographic factors, socioeconomic status, geographic location, and health plan, according to a study in JAMA.
Oseltamivir phosphate oral suspension (Tamiflu) is on back order due to increased demand, manufacturer Genentech announced.
The $20.1 billion acquisition of Genzyme by Sanofi-aventis will allow Sanotif-aventis to expand its footprint in biotechnology and give it an edge in the market for drugs for rare diseases, according to experts.
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.
FDA has issued a complete response letter for Orexigen's and Takeda's Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.
FDA has approved a vaccine for preventing meningococcal disease in children.
Recurrences of herpes zoster may be more common in immunocompetent adults than once thought, according to a study published in the February issue of Mayo Clinic Proceedings, as reported in Newswise.
Escitalopram, a selective serotonin reuptake inhibitor, at doses of 10 or 20 mg/d significantly reduced hot flash frequency and severity compared with placebo, according to a recent multi-center, double-blind study.
FDA has approved gabapentin (Gralise, Depomed and Abbott Products) tablets for once-daily treatment of post-herpetic neuralgia.
Medication errors involving analgesics, including mistakes in prescribing, are a major contributor to suboptimal therapeutic outcomes and preventable adverse patient events, according to a study published in the Journal of Pain, reported Newswise.com.
The Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices has issued revised guidelines for vaccinating patients against influenza, reported Medscape Medical News.
FDA has issued a complete response letter to Eisai for its rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive GERD, and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.
FDA has issued a complete response letter for Orexigen?s and Takeda?s Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
An increase in febrile seizures in children following vaccination with Fluzone warrants further investigation, according to a report from FDA.
Contraceptive treatments: A review of current hormone options and newer agents for women; Focus on dabigatran; Agents in late-stage development for the treatment of cystic fibrosis.
Agents in late-stage development of cystic fibrosis
Recent FDA action (through, January 2011) related to Afrezza, Nuvigil, Opana ER, Liprotamase, Erwinaze, Telaprevir, SNS01-T, XL184, QLT091001, Fidaxomicin.
