A new generic drug valsartan to treat high blood pressure and heart failures has been approved by the US Food and Drug Administration (FDA).
The report was published on the official website of FDA on 12 March 2019.
A new generic drug called Diovan, or valsartan that is known for treating high blood pressure and heart failures had been in acute shortage recently. It was said that the medicine contained nitrosamine impurities and hence a number of manufacturers recalled its production.
Nitrosamine, also called N-nitrosodimethylamine, or NDMA is a potential cancer- -causing chemical. This substance naturally comes into existence if the chemicals reactions happening during the production of some medicines are not diligently monitored.
FDA had prioritized the review of this medicine to deal with the shortage of the product in the market. Also, a few companies started charging much higher prices for the medicine, taking advantage of its shortage.
FDA reviewed the manufacturing processes of the companies producing this valsartan and made sure that all the generic drugs produced go through efficient testing mechanisms.
This testing would make sure that the valsartan product is bared of NDMA or NDEA. This would also determine that there is no risk associated with the production of any other nitrosamine impurities.
The list of drugs affected by NDMA is not limited to this one generic but also contains other drugs like irbesartan and losartan. The complete list of such drugs is available on the FDA’s website.
FDA Commissioner Scott Gottlieb, M.D said, “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. “
Scott added, “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.”
According to Indian Council of Medical Research, hypertension or increased blood pressure is a very common problem in India and is a cause of 29% of all strokes and 24% of heart attacks.
FDA has been working to ensure that the drugs supplied in the market are safe and is keeping a check on the further formation of these impurities in this or any other drug.