What You Need to Know: NDMA

FDA approves generic blood pressure drug to alleviate shortages caused by numerous recalls

Since July, the Food and Drug Administration has announced voluntary recalls of blood pressure and heart medications from Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries, Mylan Pharmaceuticals and Prinston Pharmaceuticals.

To alleviate shortages caused by these recalls, the FDA on Tuesday approved a generic form of the blood pressure medication Diovan, or valsartan.

The recalls were because the drugs valsartan, losartan and irbesartan were found to contain trace amounts of cancer causing impurities. These impurities were linked to factories in China and India that make valsartan ingredients and ship them to generic drug companies throughout the world.

“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,” FDA Commissioner Scott Gottlieb said in a press release. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”

Before approving the new drug, the FDA evaluated the company’s manufacturing processes and made sure appropriate testing methods were used to ensure there were no impurities, the press release stated. 

The FDA granted approval to manufacture the drug to Alkem Laboratories Limited, based in Mumbai, India.

When there is a drug shortage, like what is happening with valsartan and losartan, the FDA said it can expedite review of a new or generic drug application. The agency also said it is working closely with manufacturers to see if they can produce additional supplies of these medicines.

Not all lots of valsartan, irbesartan and losartan have been affected and recalled. If you aren’t sure about your medication, check the FDA website.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” Gottlieb said in an earlier statement

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