- The Food and Drug Administration approved Tuesday a generic version of the commonly-used high blood pressure medication valsartan, amid a global shortage and probe into impurities of the drug.
- The FDA had prioritized review of Alkem Laboratories' generic Diovan. Over the past few months, there have been a series of recalls due to nitrosamine impurities of drugs, including valsartan.
- "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," FDA head Scott Gottlieb said.
In December 2018, Mylan expanded a nationwide recall of its batches that contain valsartan, joining a host of other drugmakers.
Scrutiny into valsartan manufacturing has been developing since mid-2018, when the FDA and EMA backed a voluntary recall of batches of valsartan tablets that contained API produced by the Chinese manufacturer Zhejiang Huahai.
The FDA has a number of different strategies to help mitigate drug shortages and address the public health consequences, including prioritizing reviews for generics and working with manufacturers to produce additional supplies of relevant medications.
FDA scientists are also learning more about how the impurities are formed during manufacturing, and the regulator will continue to work with drugmakers to move forward approvals of angiotensin II receptor blockers that are free of nitrosamine impurities.
Last January, agency leaders said these impurities appear to come from certain chemical and reaction conditions during the manufacturing process, as well as reuse of certain materials like solvents. The findings came after the investigation, and subsequent valsartan recalls from manufacturers, widened throughout the second half of last year.
However, the regulator notes that the agency is still investigating the "root causes of the impurities."
Now that the risk of development of the nitrosamine impurities is better understood, the FDA is setting new requirements to guard against the development of these impurities in drugs — particularly valsartan, losartan and irbesartan.