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FDA approves new generic version of oft-recalled blood pressure and heart medication

How FDA drug recalls work

The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.
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The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.

The FDA approved a new generic version of valsartan, a blood pressure and heart medication drained into shortage by numerous recalls since July.

Alkem Laboratories received the approval.

Many lots of valsartan, losartan and irbesartan, drugs known as “angiotensin II receptor blockers” (ARB), have been recalled for having too much of cancer-causing impurities NDMA or NDEA. The FDA said it “prioritized the review of this drug application” to help the recent Valsartan shortage.

“When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients,” FDA commissioner Scott Gottlieb said in a statement posted on the FDA website. “As part of that work, we look at where we may be able to prioritize review of pending generic applications of the medicine in shortage, or similar products.”

The list of recalled valsartan medicines is here.

The list of recalled losartan medicines is here.

The list of recalled irbesartan medicines is here.

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Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.


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