FDA approved a new generic of Novartis’ Diovan (valsartan) amid a shortage of the blood pressure drug.
FDA prioritized the review of the generic valsartan, made by Akem Laboratories, because of multiple recalls of valsartan, ibesartan, and losartan due to carcinogenic impurities in the manufacturing process.
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“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,” said FDA Commissioner Scott Gottlieb, MD, in a statement from the agency. “So, to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”
“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,” Gottlieb added. “We’ll 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.”
For the approval of Alkem’s valsartan, FDA evaluated the company’s manufacturing processes and confirmed they used appropriate testing methods to demonstrate that the valsartan product approved does not contain the carcinogenic impurities NDMA or NDEA, the agency said. “FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.”
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