Skip to Content

Weekly News Round Up - March 7, 2012

Surfaxin Approved For The Prevention of Respiratory Distress Syndrome

First surfactant not derived from animals approved for the prevention of respiratory distress syndrome in premature infants Read More…

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

Two new pancrelipase agents, Ultresa and Viokace, approved to aid digestion Read More...

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 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.

FDA Drug Safety Update: Muscle Injuries Due To Certain Drug Interactions

Drug interactions between protease inhibitors and certain “statin” cholesterol-lowering drugs Read More...

Cholesterol-lowering drugs known as “statins” are taken by millions in the U.S., and the potential for drug interactions are sizable. This week the U.S Food and Drug Administration (FDA) warns of a serious drug interaction between certain statins and protease inhibitors, a class of anti-virals used in the treatment of human immunodeficiency virus (HIV) and hepatitis C infection (HCV). Lovastatin (Mevacor) and simvastatin (Zocor) should never be taken (are contraindicated) with HIV and HCV protease inhibitors due to the risk of muscle injury (myopathy). The most serious form of myopathy, known as rhabdomyolysis, may injure the kidneys and can be fatal. Additional dose limitations are also defined in the safety update. Healthcare providers should consult the most recent drug package labels for updated drug interaction information.

Lexapro First-Time Generic Escitalopram Now Available

Mylan Pharmaceutical launches first generic equivalent of Lexapro; Lexapro sales roughly $2.9 billion in 2011 Read More...

Over the next several years, many blockbuster drugs will lose their patent protection and go generic, with the potential to save the health care system billions of dollars. This week, Mylan launched escitalopram, the first available generic for Lexapro, an oral selective serotonin reuptake inhibitor (SSRI) antidepressant that had sales of close to $2.9 billion in 2011. Escitalopram will be available in 5, 10 and 20 mg oral tablets. Examples of other blockbusters expected to go generic in 2012 include the antipsychotic Seroquel (quetiapine, March 2012), the blood thinner Plavix (clopidogrel, May 2012), and the asthma and allergy preventative Singulair (montelukast, August 2012).

FluMist Quadrivalent: First Four Strain Flu Vaccine Approved

FluMist Quadrivalent vaccine has an extra strain of influenza B for better flu protection, especially in young children Read More...

Both the A and the B strain of the flu virus can cause death. Influenza B strains tend to affect younger school-aged children most frequently. The U.S. Food and Drug Administration has approved FluMist Quadrivalent, the first seasonal influenza vaccine that contains four strains of the influenza virus. The new flu vaccine contains two of the A strains and two of the B strains to increase efforts in flu prevention. Safety and effectiveness of FluMist Quadrivalent has been demonstrated in studies evaluating FluMist trivalent vaccine and in three new clinical trials showing that the immune response was similar between FluMist trivalent and FluMist Quadrivalent. Both vaccines contain the live influenza nasal vaccine approved for use in  2 through 49 years of age.