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US Food and Drug Administration 

FDA approves new generic valsartan to address shortages

Scott Gottlieb, FDA commiossioner


Scott Gottlieb, commissioner of the US Food and Drug Administration, said the body has “prioritised the review of generic applications for these valsartan products” to address the public health consequences of recent medicines shortages

The US Food and Drug Administration (FDA) has approved a new generic valsartan (Diovan; Alkem Laboratories Ltd) to help relieve recent shortages of the medicine.

Valsartan shortages have occurred as a result of multiple recalls of generic valsartan products from several manufacturers after they, and other angiotension II receptor blocker (ARB) medicines used to treat high blood pressure and heart failure, were found to be contaminated with nitrosamine impurities.

“We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines,” said FDA commissioner Scott Gottlieb, who is due to resign in April 2019.

He continued: “So to address the public health consequences of these shortages, we’ve prioritised the review of generic applications for these valsartan products.

“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products.”

For the approval of this new generic, the FDA evaluated the company’s manufacturing processes to make sure that they used appropriate testing methods to demonstrate that it did not contain N-nitrosodiethylamine or N-nitrosodimethylamine (better known as NDEA and NDMA, respectively).

In July 2018, pharmacies across the EU were advised to recall all batches of valsartan-containing medicines made by Dexcel Pharma Ltd and Accord Healthcare (previously known as Actavis Group), after an impurity was unexpectedly identified as part of Zheijang Huahai Pharmaceutical’s manufacturing process.

A further product recall for heart and blood pressure drug valsartan was then issued by the Medicines and Healthcare products Regulatory Agency in December 2018 to include batches of the medicine that contain drugs supplied by Teva and Mylan.

The FDA continues to investigate ARB medicines that contain nitrosamine impurities and fail to meet quality standards. It will continue to update the lists on its website of recalled valsartan, losartan and irbesartan products as more information becomes available from ongoing testing. 

In the UK, the government has issued price concessions for 16 sartan medicines in February 2019.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206283

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