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Weekly Drug News Round Up - April 2, 2014

FDA Approves Oralair Allergen Extract for Grass Pollen Allergies

Oralair is a once-daily tablet that rapidly dissolves after it is placed under the tongue Read More...

The U.S. Food and Drug Administration (FDA) has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergenic Extract) to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is caused by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. Oralair can be taken at home after the first dose, which is given in the clinic. People affected by hay fever may suffer from repetitive sneezing, nasal itching, runny nose, nasal congestion, and itchy and watery eyes and often have to allergy shots.

Oralair: need link

Biogen Idec’s Orphan Drug Alprolix Approved for Hemophilia B

Hemophilia B affects about 3,300 people in the United States Read More...

Hemophilia B is an inherited sex-linked, blood-clotting disorder, which primarily affects males, and is caused by defects in the Factor IX gene. The U.S. Food and Drug Administration (FDA) has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require fewer injections. Alprolix consists of the Factor IX molecule linked to the protein fragment Fc found in antibodies. This makes the product last longer in circulation. Clinical studies in 123 individuals with severe Hemophilia B, ages 12 to 71 demonstrated the effectiveness and safety of Alprolix.

Janssen’s Topamax FDA-Approved for Adolescent Migraine Prevention

Roughly 12 percent of the U.S. population experiences migraine headaches Read More...

The U.S. Food and Drug Administration (FDA) has approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 to 17. Topamax is the first drug approved for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches; it is not used to treat an ongoing migraine headache. A clinical trial of 103 participants treated with Topamax at the approved daily dose of 100 milligrams experienced a decrease in the frequency of migraine of approximately 72 percent compared to 44 percent in participants that took an inactive drug (placebo).

Pfizer Announces Approval of Over-the-Counter Nexium 24HR

In 2012, Pfizer acquired exclusive global rights from AstraZeneca to market non-prescription Nexium Read More...

The mega-blockbuster Nexium (esomeprazole magnesium) has been approved for over-the-counter (OTC) use by the U.S. Food and Drug Administration (FDA). The newly marketed OTC - Nexium 24HR - is a proton pump inhibitor used for gastroesophageal reflux disease (GERD), otherwise known as heartburn. The prescription product Nexium is indicated for treatment of erosive esophagitis, gastroesophageal reflux disease (GERD) and for use in eradication of H. pylori to reduce the risk of duodenal (intestinal) ulcer recurrence. Nexium reaped in over $6 billion in 2013 and has long been ranked in the top 5 drugs by sales.

GlaxoSmithKline Recalls All Lots of Alli Weight Loss Product

If patients have consumed questionable product, they should contact their healthcare providers for further instructions Read More...

GlaxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling all Alli (orlistat) weight loss products from U.S. and Puerto Rico retailers as the company believes that some packages of the product were tampered with and may contain product that is not authentic Alli. Alli is a turquoise blue capsule with a dark blue band imprinted with the text “60 Orlistat”. It is packaged in a labeled bottle that has an inner foil seal imprinted with the words: “Sealed for Your Protection.” Consumers who have concerns about the product they have purchased should not use it and call GSK at 800-671-2554.