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US FDA approves new generic blood pressure drug to address ongoing shortage

The U.S. Food and Drug Administration approved Alkem Laboratories Ltd.'s new generic version of common blood pressure and heart failure drug valsartan, in an attempt to relieve shortages stemming from mass recalls of the medicine.

According to the FDA's March 12 press release, the agency prioritized Alkem's generic-drug review and ensured that the India-based pharmaceutical company's manufacturing process did not result in cancer-causing nitrosamine impurities containing N-nitrosodimethylamine, or NDMA, and N-nitrosodiethylamine, or NDEA.

The carcinogenic impurities had been found in batches of valsartan medications from Mylan NV and Teva Pharmaceutical Industries Ltd.

The ongoing recalls in the U.S. and Europe, which first began in July 2018, now also include losartan and irbesartan products. Valsartan, losartan and irbesartan are angiotensin II receptor blockers, or ARBs.

The FDA said it will continue to work with drug manufacturers to evaluate and expedite ARB drug applications that address the shortage, as well as provide additional supplies of anti-hypertensive medicines.

In the meantime, the FDA's list of recalled products will be updated accordingly as the investigation into ARB drugs continues.