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Octapharma gets orphan drug status for Wilate

BY Alaric DeArment

HOBOKEN, N.J. The Food and Drug Administration has given orphan drug designation to a treatment for an inherited bleeding disorder that occurs in fewer than 1-in-1,000 people.

Octapharma USA announced that the FDA had given the designation to the drug Wilate (von Willebrand factor/factor VIII concentrate, human), a treatment for von Willebrand disease. The FDA grants orphan drug designation to treatments for rare diseases.

Von Willebrand disease causes bleeding episodes in patients, either spontaneously or as a result of trauma.

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Smiling Planet announced partnership with Healthy Child Healthy World

BY Allison Cerra

LOS ANGELES Smiling Planet a new line of earth-friendly lifestyle products for kids, has joined the Healthy Child Healthy World network.

The partnership represents a joint commitment to raising awareness about preventing children’s exposure to harmful chemicals, and also reinforces the high standards of safety, quality, and environmental consciousness that Smiling Planet sets for its children’s dinnerware. Smiling Planet’s plates and bowls are specifically designed to be a safe and practical alternative to dinnerware containing melamine, BPA and other harmful chemicals, Smiling Planet said.

“Today’s parents are inundated with conflicting information about product safety, often leaving them unsure about which products are best,” said Freddy Deane, who co-founded Smiling Planet with wife Olivia Haviland. “We’re proud to join Healthy Child Healthy World to empower parents to find the safest possible products for their children, and for the planet.”

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Sagent’s generic Imitrex receives regulatory approval

BY Alaric DeArment

SCHAUMBURG, Ill. The Food and Drug Administration has approved a generic injected drug made by Sagent Pharmaceuticals for treating migraine attacks, Sagent said Monday.

 

The FDA approved Sagent’s sumatriptan succinate injection in the 6 mg per 0.5 milliliter strength. The drug is used to treat acute migraine attacks and cluster headache episodes.

 

 

Sumatriptan is a generic version of GlaxoSmithKline’s Imitrex. Injectable sumatriptan had $22 million in sales in 2009, according to IMS Health.

 

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