Healthcare Industry News:  valproic acid 

Biopharmaceuticals FDA

 News Release - June 22, 2007

FDA Approves Carnitor(R) SF (Levocarnitine) Sugar-Free Oral Solution For Patients With Carnitine Deficiency

GAITHERSBURG, Md., June 22 (HSMN NewsFeed) -- The Food and Drug Administration has announced the approval of Carnitor® SF (levocarnitine) Sugar-Free Oral Solution for the same indication approved for the current Carnitor® Oral Solution containing sugar. Carnitor® SF and Carnitor® Oral Solution are indicated to treat primary systemic carnitine deficiency and for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.

Adverse events reported with Carnitor® use include nausea, vomiting, body odor, gastritis, and seizures. There were no contraindications or warnings. Please see full prescribing information.

Primary systemic carnitine deficiency is a very rare genetic disorder that typically presents in infants. Secondary carnitine deficiency may present in infants, children, and adults. Factors contributing to carnitine deficiency may include inborn errors of metabolism, fanconi syndrome, chronic renal dialysis, carnitine-deficient diet, extreme prematurity, malabsorption, HIV infection or antiretroviral therapy, valproic acid (VPA) and a Ketogenic Diet. Symptoms of secondary carnitine deficiency may include cardiomyopathy, encephalopathy, muscle weakness, anemia, and fatigue.

Carnitor® SF, the sugar-free version of levocarnitine, is appropriate for patients with carnitine deficiency for whom a sugar-free option is desirable. This may include patients with diabetes or those who are on a Ketogenic Diet who need to limit sugar and carbohydrates.

"We are pleased to be able to offer a sugar-free version of Carnitor® for patients who are diabetic or those who are on a Ketogenic Diet, those who are intolerant or have sensitivities to sugar and develop carnitine deficiency," said Gregg Lapointe, Sigma-Tau Chief Operating Officer. "In keeping with Sigma-Tau's commitment to rare diseases, we are pleased to provide this new option for this important group of patients.

Carnitine functions in the body as a carrier of fatty acids to the energy centers in muscles (mitochondria). A deficiency of carnitine, normally produced by the liver and kidneys, can result in extreme muscle weakness and other related symptoms.

"Previously there was nothing available for patients with carnitine deficiency who needed to limit sugar intake, especially children with diabetes or those on a Ketogenic Diet," said Dr. Darryl De Vivo, Associate Chairman (Neurology) for Pediatric Neurosciences at Columbia University Medical Center. "Carnitine deficiency is a debilitating illness, so it is reassuring to know that these patients can still treat their symptoms without complicating their condition with undue sugar intake."

Carnitor® SF (levocarnitine) Sugar-Free Oral Solution is the only U.S. FDA approved prescription sugar-free oral solution of levocarnitine available. The product is expected to be available June 22, 2007.

About Sigma-Tau Pharmaceuticals, Inc.

Sigma-Tau Pharmaceuticals, Inc. is a U.S. based, wholly owned subsidiary of the Sigma-Tau Group, and is dedicated solely to the global development and commercialization of medicines for patients with rare diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland.

Since 1989, the company's products have been focused on rare diseases, kidney disease, and cancer. With more than 6,000 identified rare diseases that affect approximately 25 million patients in the United States, Sigma-Tau places its considerable scientific resources behind the discovery of compounds that benefit the few. The company has a substantial development program focused on transplant, cancer, inherited genetic disorders, malaria, as well as other areas of unmet medical need. For more information about the company, visit www.sigmatau.com.


Source: Sigma-Tau Pharmaceuticals

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