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Monthly News Round Up - March 2012

Omontys Approved For Dialysis Patients with Anemia Due to Chronic Kidney Disease

The U.S. Food and Drug Administration (FDA) has approved Omontys (peginesatide), a once-a-month erythropoiesis-stimulating agent (ESA) for anemia of chronic kidney disease (CKD) in patients receiving dialysis. Omontys should not be used in patients with CKD who are not receiving dialysis or who have cancer-related anemia due to the risk for cardiovascular adverse events. Omontys stimulates red blood cell production in the bone marrow, increases hemoglobin (Hb) counts, and lowers the need for blood transfusions. Omontys is dosed once monthly, compared to ESAs such as Epogen or Procrit, that are dosed up to three times weekly.

QNASL Now Approved For Allergic Rhinitis

Nasal corticosteroids are often the first drug of choice when treating allergic rhinitis symptoms such as a runny nose, watery eyes, and sneezing. But some patients do not tolerate the liquid nasal spray that may drip down the back of the throat. QNASL, a nonaqueous, or "dry" form of the nasal aerosol beclomethasone diproprionate, has been FDA-approved for seasonal and year-round allergic rhinitis. QNASL, the only nonaqueous allergic rhinitis corticosteroid available on the U.S. market, is approved for use in adults and adolescents 12 years and older. Four clinical trials demonstrated effectiveness of a 320-microgram dose delivered by two sprays in each nostril once daily. Teva Pharmaceuticals markets QNASL.

Surfaxin Approved For The Prevention of Respiratory Distress Syndrome

Premature infants cannot make enough lung surfactant to keep their lungs open for proper breathing and may develop respiratory distress syndrome (RDS) resulting in a lack of oxygen shortly after birth. Surfaxin (lucinactant), the first synthetic surfactant has been FDA-approved for the prevention of RDS in premature, high-risk infants. Surfaxin showed significant improvement in RDS symptoms and related mortality at 24 hours after birth and at two weeks compared to Exosurf (no longer marketed). Other available FDA-approved surfactants include Survanta (beractant), Curosurf (poractant alpha), and Infasurf (calfactant). Launch of Surfaxin is not expected until late 2012.

New Pancreatic Enzyme Products Ultresa and Viokace Approved

In the body, the pancreas manufactures enzymes that are needed to aid in food digestion. These enzymes may not be available in sufficient quantities in patients with cystic fibrosis (CF), chronic inflammation of the pancreas (pancreatitis), or those who lack some or all of their pancreas. The U.S. Food and Drug Administration has approved two new drugs, Ultresa (pancrelipase) and Viokace (pancrelipase), to help to replace these missing enzymes. Ultresa is a delayed-release capsule approved for children and adults with CF. Viokace is used in combination with a proton-pump inhibitor for adults with pancreatitis or missing some or all of their pancreas.

Binosto Approved For Osteoporosis: Effervescent Form Easier to Swallow

The U.S. Food and Drug Administration has approved Binosto (alendronate), a buffered effervescent dosage form of the bisphosphonate drug alendronate sodium. Binosto is administered once-weekly for the treatment of osteoporosis in postmenopausal women and in men. Binosto comes as a 70-mg, strawberry-flavored tablet that is dissolved in four ounces of water prior to drinking, making administration easier for patients who have trouble swallowing tablets. Alendronate is currently available in the U.S as an oral tablet or solution (Fosamax) or as the generic alendronate tablet. Binosto should be available in U.S. retail markets in the third quarter of 2012.

Posted: March 2012


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