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Weekly Drug News Round Up - January 23, 2013

FDA Approves Expanded Uses for Exjade

FerriScan imaging agent is also authorized to use in conjunction with Exjade to determine liver iron concentrations Read More...

The U.S. Food and Drug Administration (FDA) has approved Exjade (deferasirox) to remove excess iron in a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT). Thalassemia typically results in fewer red blood cells (RBC) and less hemoglobin, a protein that carries oxygen throughout the body. According to the FDA, an estimated 1,000 people in the United States have thalassemia. NTDT is a milder form of thalassemia that does not require frequent RBC transfusions, but patients may still be at risk for iron overload that can damage vital organs.

Zecuity Approved in a Patch Form of Sumatriptan for Migraines

Most frequent side effects were injection site pain, tingling, itching, warmth and discomfort Read More...

NuPathe’s Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, a common migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and nausea. Zecuity clinical trials demonstrated that after two hours 18 percent of patients were headache-free compared to nine percent using placebo, and roughly 50 percent of patients had a reduced headache compared to 29 percent in the placebo group. Over 80 percent of patients in the active group had nausea relief, compared to 63 percent on placebo. Cost may be a concern, as sumatriptan is also available as a lower-cost generic in an oral tablet, nasal spray and injection form.

FDA Okays New Indication for Botox

Botox is injected into the bladder muscle causing it to relax and have a greater capacity Read More...

The U.S. Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) for treatment of adults with overactive bladder who do not respond to or are intolerant of a class of drugs called anticholinergics. Botox is indicated for use in adults with symptoms of leakage, frequent urination and feeling the sudden and urgent need to urinate. Clinical trials in over 1100 patients demonstrated that after 12 weeks those treated with Botox had urinary incontinence roughly 1.5 to 2 times less per day than people treated with a placebo. Botox Cosmetic is also available to treat facial wrinkles.

Flublok Influenza Vaccine Manufactured With New Technology

Flublok is approved for flu prevention in adults 18 to 49 years of age; Flublok shelf life is only16 weeks Read More...

The U.S. Food and Drug Administration has approved Flublok (influenza vaccine, recombinant hemagglutinin), the first trivalent influenza vaccine made using an insect virus and recombinant DNA technology. The novel technology allows for faster production of large quantities of the flu protein hemagglutinin (HA). Flublok contains three, full-length, recombinant HA proteins to help protect against influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain. The safety and effectiveness of Flublok was shown in clinical trials of over 4,800 people. Flublok was roughly 45 percent effective against all circulating influenza strains.

Octaplas Approved for Blood-Clotting Disorders

Octaplas has been used extensively in Europe and other countries Read More...

The U.S. Food and Drug Administration has approved Octapharma’s Octaplas, a pooled human plasma product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Octaplas is treated with a solvent detergent process to reduce the risk of serious virus transmission. Clotting protein deficiencies can cause excessive bleeding or excessive clotting. Octaplas is indicated for use in patients with liver disease, undergoing heart surgery or liver transplantation, or for those with thrombotic thrombocytopenic purpura (TTP). The FDA considers Octaplas a viable alternative to single-donor Fresh-Frozen Plasma.