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Weekly Drug News Round Up - December 26, 2012

FDA Approves Orphan Drug Juxtapid for Rare Cholesterol Disorder

FDA approved Juxtapid with a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use Read More...

Homozygous familial hypercholesterolemia (HoFH) is a rare condition in which patients cannot remove unwanted LDL (bad) cholesterol from the body. Patients with HoFH often die before age 30 due to heart attacks. The U.S. Food and Drug Administration (FDA) has approved Juxtapid (lomitapide), a once-a-day oral capsule to reduce lipoproteins in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments. In a clinical trial of 29 patients, LDL cholesterol fell by approximately one-half during the first 26 weeks among patients who tolerated the drug.

Adasuve Approved for Agitation in Schizophrenia or Bipolar I Disorder

Adasuve projected to be available for commercial launch early in the third quarter of 2013 Read More...

Adasuve (loxapine) has been approved for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Adasuve is a powder available via a hand-held inhaler and delivers the drug to the lungs. Adasuve exhibited rapid effects in agitated patients with statistically significant reductions in agitation starting at 10 minutes following administration. Adasuve was approved with a Boxed Warning detailing the risk of bronchospasm and increased risk of mortality in the elderly with dementia-related psychosis. Adasuve will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

FDA Approves Varizig to Reduce Chickenpox and Shingles Symptoms

Varizig is designated as an orphan drug and received priority review by the FDA Read More...

Most people in the United States have immunity to varicella zoster virus (VZV) from vaccination or from having had chickenpox during childhood. VZV is the virus that causes chickenpox in children and shingles in adults. However, people without VZV immunity who are exposed to the virus may experience severe, sometimes fatal infections. The U.S. Food and Drug Administration (FDA) has approved Varizig (varicella zoster immune globulin) - shown to lower the risk of severe infections if given within four days after exposure. Varizig is approved for immunocompromised children and adults, newborns, pregnant women, premature infants, children under one year, and adults with no VZV immunity.

Gattex Approved for Short Bowel Syndrome

Gattex approved with a Risk Evaluation and Mitigation Strategy (REMS) communication plan due to possible serious side effects Read More...

Short bowel syndrome (SBS) is a condition due to the partial or complete surgical removal of the small and/or large intestine which results in poor absorption of nutrients. Patients with SBS often require nutrition injected into the veins. The U.S. Food and Drug Administration (FDA) has approved Gattex (teduglutide) injection to treat adults with SBS who need additional nutrition from intravenous feeding. In clinical trials, Gattex led to at least a 20 percent reduction in the volume of weekly parenteral nutrition after 20 and 24 weeks of treatment. Zorbtive (somatropin) and Nutrestore (glutamine) are also approved to treat adults with SBS receiving nutritional support.

Tamiflu Approved to Treat Flu in Children at Least Two Weeks Old

Tamiflu use for the prevention of flu in pediatrics is still only approved in children one year of age and older Read More...

According to the Centers for Disease Control and Prevention, children younger than two years are at higher risk for developing flu complications. The U.S. Food and Drug Administration has expanded the pediatric indications for Tamiflu (oseltamivir) influenza treatment to include children older than two weeks of age and within 48 hours of having flu symptoms. The dosing for influenza treatment in children older than 2 weeks to one year of age is three milligrams per kilogram twice daily for five days and is based on the individual weight of the child. Pharmacists dispensing Tamiflu must be sure to provide the properly calibrated oral dispenser when filling prescriptions.