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Kashi introduces organic cereals

BY Allison Cerra

LA JOLLA, Calif. — Kashi has launched two USDA-certified organic cereals that combine organic corn flakes with a touch of natural sweetness.

Kashi Simply Maize — made with whole organic corn that is puffed into hearty, crisp flakes with a touch of molasses — and Kashi Indigo Morning — which combines a delicious blend of crispy, golden, organic corn flakes with real blueberries and blackberries — are certified organic cereals and are free of preservatives, artificial flavors and high-fructose corn syrup.

The cereals now are available at retailers nationwide for a suggested retail price of $3.99.

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Supernus gets preliminary nod for epilepsy drug

BY Alaric DeArment

ROCKVILLE, Md. — The Food and Drug Administration has given tentative approval to Supernus Pharmaceuticals for a drug to treat epilepsy, the company said Tuesday.

Supernus announced the tentative approval was given to Trokendi XR (topiramate), a once-daily treatment for the seizure disorder. The company said final approval was conditioned on resolution of market exclusivity issues concerning certain pediatric populations.

"We are pleased to announce that the FDA has granted us tentative approval for Trokendi XR and that all of the scientific and procedural conditions for approval have been met," Supernus CEO, president and director Jack Khattar said. "We will continue to work closely with the FDA to further understand the outstanding issue and move forward toward final approval."


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Watson seeks approval for generic antidepressant

BY Alaric DeArment

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection on an antidepressant made by Pfizer, the company said.

Watson filed a regulatory approval application with the Food and Drug Administration for desvenlafaxine succinate extended-release tablets in the 50-mg and 100-mg strengths. The drug is a generic version of Pfizer’s Pristiq.

Watson’s application included a paragraph IV certification, a legal assertion that patents covering the branded drug are invalid, unenforceable or won’t be infringed, and the company said it was the first to file a complete application for a generic version of Pristiq. In response, Pfizer and others filed suit against Watson Friday in the U.S. District Court for the District of Delaware to try and prevent Watson from commercializing its product before the expiration of U.S. Patent No. 6,673,838, which is set to expire in 2022. The suit puts a stay of approval on Watson’s drug until August 2015 or until the companies settle the case.

Pristiq had sales of about $559 million during the 12-month period ended in April, according to IMS Health.


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