PHARMACY

FDA approves Kowa Pharmaceuticals’ statin

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for lowering cholesterol.

The FDA announced Monday the approval of Livalo (pitavastatin), manufactured by Montgomery, Ala.-based Kowa Pharmaceuticals.

Like other statins, the drug is designed for patients for whom diet and exercise have failed to lower cholesterol levels. Statins lower cholesterol by inhibiting HMG Co-A reductase, a liver enzyme involved in the liver’s manufacture of cholesterol.

“Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke,” FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology Products deputy director Eric Colman said in a statement. “Today’s approval offers patients and their healthcare professionals another alternative way to treat high cholesterol.”

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Caraco settles patent suit over cancer generic

BY Alaric DeArment

DETROIT A generic drug maker announced Monday that it had settled patent litigation over a generic version of a cancer drug.

Caraco Pharmaceutical Labs said it reached a settlement with MedImmune over a generic version of the drug Ethyol (amifostine). MedImmune had filed the suit in the U.S. District Court for the District of Maryland.

Under the settlement, MedImmune granted Caraco a license to certain patents that permit Caraco to continue marketing its generic version of Ethyol in the United States.

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Biosimilars bill passed by House committee draws response from GPhA

BY Alaric DeArment

NEW YORK A House committee vote has brought a pathway for biosimilars one step closer to reality, but not in a way that pleases everyone.

The House Energy and Commerce Committee voted 47-11 Friday to pass an amendment to the healthcare reform bill that would give biotech drugs 12 years of market exclusivity before they face competition from biosimilars.

“We are sincerely disappointed that some members of the House Energy and Commerce Committee have decided to put brand pharmaceutical profits before patient needs,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger said in a statement. “The amendment passed tosses patient needs out the window.”

In March, Reps. Henry Waxman and Anna Eshoo, both California Democrats, sponsored competing bills in Congress to allow a regulatory pathway for biosimilars. Waxman’s bill would give biotech drugs five years’ market exclusivity before facing biosimilar competition, like the Hatch-Waxman Act of 1984, which created a pathway for generic pharmaceutical drugs. Eshoo’s bill would grant 12 to 14 years of exclusivity. The short-exclusivity plan has the support of the generic drug industry, patient advocates, pharmacy trade groups and The Washington Post editorial page, though legislation to allow longer exclusivity periods has advanced further in the House and Senate.

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