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March 14, 2019

FDA approves new generic heart drug amid shortage

Daily Briefing

    FDA on Tuesday announced it has approved a new generic blood pressure and heart failure medication to help address a shortage that resulted from multiple drug recalls.

    Background: FDA, manufacturers recall heart drugs containing cancer-causing chemicals

    FDA and drug manufacturers in July 2017 began recalling various valsartan blood pressure and heart failure treatments, after the agency found some of the medications tested positive for the organic chemical N-nitrosodimethylamine, which is an impurity the International Agency for Research on Cancer has classified as a probable human carcinogen.

    FDA in January said the impurities were chemical byproducts of processing the drugs' active ingredients, which include irbesartan, losartan, and valsartan. FDA noted valsartan products were "in shortage," and said recalls might cause additional shortages of the medications.

    FDA approves new generic heart drug 

    To address the shortage, FDA said it prioritized the review of new generic versions of valsartan products. FDA evaluated and approved Alkem Laboratories Limited's generic valsartan drug after verifying it did not contain chemical impurities.

    FDA Commissioner Scott Gottlieb said the agency hopes the "approval of this new generic will help reduce the valsartan shortage." He said FDA "remain[s] committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products."

    According to USA Today, Alkem did not respond to a request for comment on how the company plans to sell the drug in the United States (Alltucker, USA Today, 3/12; Grady, New York Times, 3/12; Lou, MedPage Today, 3/12).

    Drug shortages—and 6 other executive briefings on key pharmacy topics

    While historically pharmacy may have been viewed as a cost center, today pharmacy services generate a significant portion of system revenues and are essential to the achievement of strategic system-level priorities.

    To better understand increasingly complex pharmacy issues and the critical role pharmacy plays in overall health system success, download our executive briefings on hot pharmacy topics.

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