On March 12, 2019, the FDA approved an ANDA for Valsartan “to help relieve the recent shortage of this critical 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.” The Agency prioritized the ANDA’s approval but is it not yet clear how quickly the FDA approved the ANDA or when it was submitted as it is not yet listed on the approval site or in the Orange Book.
The FDA has the ability to expedite the approval of an application by prioritizing the review and inspections associated with it when there is a documented shortage of a drug product, and it did so in this instance. The FDA notice (here) states that “[F]or this approval, the FDA evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA. The FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.”
There are other Angiotensin II Receptor Blocker (ARB) products that have been implicated with the impurities and it is likely that the Agency is currently taking the same action on ANDAs for other single‑entity or combination products that have been found not to contain the nitrosamine impurities. However, until such time as there is another FDA announcement, all we can do is speculate.
The FDA also notes that it will continue to monitor the impurity situation with the ARB products and will update its site for recalled products of this class.
