Alkem gets FDA nod for generic Diovan
The Food and Drug Administration has cleared Alkem Laboratories’ generic Diovan (valsartan).
Valsartan is an angiotensin II receptor blocker that treats high blood pressure and heart failure.
The FDA prioritized the review of this drug application to help relieve the recent shortage of this medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.
“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 said.
Gottlieb continued, “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products. When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. 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. 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.”
Valsartan is an angiotensin II receptor blocker that treats high blood pressure and heart failure.
The FDA prioritized the review of this drug application to help relieve the recent shortage of this medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.
“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 said.
Gottlieb continued, “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products. When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. 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. 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.”