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Fresenius Kabi wins US FDA award for relieving drug shortage

By Staff Reporter

- Last updated on GMT

(Image: Getty/Nevodka)
(Image: Getty/Nevodka)

Related tags: Fresenius kabi, Fda, Puerto rico

The FDA provided Fresenius Kabi helped with a Drug Shortage Assistance Award for providing IV saline solution during the Puerto Rico hurricane crisis.

A number of manufacturers had their operations on Puerto Rico disrupted, after hurricane Maria struck the island last year​, which resulted in a shortage of certain products.

Fresenius worked with the US Food and Drug Administration (FDA) center for Drug Evaluation and Research’s Office of Drug Shortages to alleviate shortages of sodium chloride injection USP, 0.9% bags.

In addition, the FDA’s letter of recognition for Fresenius’ efforts noted that the company provided additional supplies of the product, after obtaining approval of its abbreviated new drug application.

“FDA established this award program to recognise companies for making a substantial contribution to preventing or alleviating a drug shortage. FDA hopes this award serves as an incentive for other companies to assist in addressing drug shortages, as Fresenius Kabi has done,” ​stated the letter.

The incidence of drug shortages rose in 2017, when compared with 2016 – up to 35 from 23. However, the agency has noted that it successfully prevented 132 drug shortages in 2017.

Overall, the agency suggested that shortages were lower than had been experienced in previous years and noted that this was due to earlier notification from companies and a focus on high-quality manufacturing. The agency has also set up a drug shortages taskforce​ to minimise preventable shortages.

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