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FDA approves Shire autoimmune disorder drug

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

The FDA announced the approval of Firazyr (icatibant) for acute attacks of hereditary angioedema in patients ages 18 years and older. HAE, which affects fewer than 30,000 people in the United States, results from improper function of C1 inhibitor, a protein that regulates how certain immune system and blood clotting pathways function.

People with the condition can develop rapid swelling of the hands, feet, limbs, face, intestinal tract and other internal organs, which can lead to disfigurement, disability and death.

"Firazyr provides a new option to treat acute attacks of HAE and because it can be self-administered through an injection in the abdominal area, patients can treat themselves upon recognition of an HAE attack," FDA Office of Drug Evaluation II director Curtis Rosebraugh said.

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Rite Aid stocks extra emergency supplies ahead of Hurricane Irene

BY Alaric DeArment

CAMP HILL, Pa. — With Hurricane Irene barreling up the East Coast and expected to make landfall in the Northeast this weekend, Rite Aid is stocking extra emergency supplies in its stores in affected regions, the retail pharmacy chain said.

Rite Aid stores in three states have increased supplies of bottled water, batteries, flashlights, canned foods, first aid supplies, disposable cameras and other items.

The American Red Cross recommends having a seven-day supply of medications and medical supplies, such as syringes, hearing aid batteries and glucose testing strips on hand.

Meanwhile, the Food and Drug Administration is urging people not to use food or drugs damaged by flood waters and to keep a supply of clean water available.

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AccuDial: Parent-tested, parent-approved

BY Michael Johnsen

PALM BEACH GARDENS, Fla. — AccuDial Pharmaceutical on Thursday announced its Children’s AccuDial line of pediatric medications featuring the company’s accurate weight-based dosing label has been awarded the PTPA Winner’s Seal of Approval.

“Winning the PTPA Winner’s Seal of Approval is both humbling and exciting for AccuDial Pharmaceutical,” AccuDial chairman and CEO Robert Terwilliger said. “We found that by leveraging innovative technology, AccuDial’s labeling system is able to meet both a functional and emotional need in consumers that resonates in the market.”

PTPA Media consists of North America’s largest volunteer parent testing community, with more than 40,000 parents. Because independent parent volunteers evaluate these products in their own homes, PTPA winners are chosen based on merit and consumer experience — not on commercial considerations, the company stated.

“At PTPA Media, we are proud to play a role in certifying innovative products that families can trust,” PTPA Media CEO Sharon Vinderine said. “When consumers search for our Seal of Approval on product packaging and websites, they are essentially searching for validation from their peers. Their peers will have objectively tested and approved these products based on their performance in a real life environment. That type of resource for families is priceless.”

AccuDial also announced the company will soon launch Children’s Pain and Fever with acetaminophen in five flavors: cherry, dye-free cherry, bubblegum, strawberry and grape.

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