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FDA Approves New Generic Valsartan to Ease Shortage

Certain lots of valsartan recalled due to contamination with trace amounts of nitrosamine

WEDNESDAY, March 13, 2019 (HealthDay News) — The U.S. Food and Drug Administration on Tuesday approved a new generic version of the high blood pressure/heart failure drug valsartan, saying the move might help ease the current medication shortage.

The agency said it prioritized review of the drug from Alkem Laboratories Ltd. after multiple recalls of other generic valsartan products depleted supplies. Those recalls occurred because certain lots of valsartan and other angiotensin II receptor blocker (ARB) medicines were found to contain trace amounts of nitrosamines.

“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, M.D., said in an agency news release. “We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products.”

In the case of this new generic drug, the FDA said it assessed the company’s manufacturing processes to ensure there is no risk for the formation of nitrosamine impurities. The agency said it also confirmed the company used appropriate testing methods to ensure that the newly approved generic valsartan product is not contaminated. The FDA added that it continues to investigate ARB medicines that contain nitrosamine impurities and fail to meet the agency’s quality standards. In addition, the agency will “continue to work with manufacturers so that more medicines like valsartan can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage,” Gottlieb said.

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