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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