Author: Ken Alltucker / Source: USA TODAY
The Food and Drug Administration posted information on its website listing the blood pressure medications recalled for containing carcinogens. Here’s what to watch out for. USA TODAY
The Food and Drug Administration on Tuesday approved a new generic version of valsartan to alleviate recent shortages of the blood pressure medication following a series of safety recalls.
There have been more than 15 recalls of generic versions of the commonly-prescribed blood pressure and heart medications valsartan, losartan and irbesartan that contained trace amounts of probable carcinogens.
FDA Commissioner Scott Gottlieb said the recalls of valsartan that contained nitrosamine impurities “resulted in a shortage of these important medicines.”
Gottlieb said the agency prioritized review of applications for new generic versions to address the drug’s shortage. The drug’s brand version, Diovan, has not been recalled.
The FDA said it evaluated Alkem Laboratories Ltd.’s manufacturing and testing to verify its valsartan does not contain impurities found in competitors’ recalled blood pressure drugs.
Mumbai, India-based Alkem did not immediately respond to questions about the company’s plans to sell the drug in the United States.
“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing…
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