FDA speeds approval for generic valsartan amid shortage

The FDA fast-tracked the approval process for a new generic valsartan product (Diovan) amid an ongoing shortage of the blood pressure and heart failure medication.

The shortage has been exacerbated by a series of angiotensin II receptor blocker (ARB) recalls over carcinogenic impurities, but the FDA hopes this new approval—announced March 12—will help patients who need these medications.

“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,” outgoing FDA Commissioner Scott Gottlieb, MD, said in a statement. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan 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.”

Three different carcinogens have been detected in sartan drugs, including valsartan, losartan and irbesartan, since last summer. In most cases, the FDA said the impurities were introduced as a result of changes in manufacturing processes. The agency has repeatedly suggested patients taking the recalled medications should continue doing so until agreeing on an alternative with their pharmacist or healthcare provider, as the risk of cancer is much lower than the risk of problems related to stopping or interrupting therapy.

The approval for the new generic valsartan (Diovan) was granted to Alkem Laboratories, an India-based company whose manufacturing facility was inspected by the FDA in January.