FDA Green Lights New Generic Valsartan
The FDA approved Diovan, Alkem Laboratories’ new generic of valsartan for treating high blood pressure and heart failure.
The agency said that it prioritized the drug application’s review to help stave off recent shortages due to recalls of generic valsartan products.
After assessing Alkem’s manufacturing processes, the agency concluded that no known risks existed for other nitrosamine impurities. The agency said it made sure the company “used appropriate testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA.”