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Swift US approval for Baxter’s nutritional supplement

FDA backs Clinolipid to alleviate shortage of drugs for people unable to eat or drink

Baxter building 

The US Food and Drug Administration (FDA) has approved Baxter's Clinolipid as an intravenous nutritional supplements for adult patients unable to eat or drink.

The approval comes after the drug received priority review status from the US regulator due to the shortage of products available for patients in this condition.

Priority review status is reserved for treatments that offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

It means the FDA looks to complete its review within six months rather than the standard 10 month period.

There are a total of 242 products listed in the FDA' drug shortage list, 16 of which are for parenteral nutrition.

“The FDA has been very concerned about the short supply of injectable lipid emulsion products,” said Dr Donna Griebel director of the Division of Gastroenterology and Inborn Errors Products at the FDA.

“Today's approval of Clinolipid will help in the effort to resolve this shortage so that patients have access to these parenteral nutrition products.”

The hastened approval is even more noticeable given the FDA is one of the major government organisations affected by the ongoing US shutdown

Clinolipid contains a mixture of refined olive oil and refined soybean oil, serving as a source of energy for adult patients unable to receive nutrition in the standard way.

It has demonstrated in clinical trials that its ratio of fatty acids it has a similar safety and efficacy as other available lipid emulsion products.

The FDA warned Clinolipid “should be used with caution in patients with pre-existing liver disease or liver insufficiency”, and no patient with allergies to eggs or soy beans should be given the supplement.

It is also not recommended for use in children because it is not known whether the amount of essential fatty acids found in Clinolipid is enough to meet their nutritional needs.

Article by
Thomas Meek

7th October 2013

From: Sales

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