FDA News

FDA approves new generic valsartan to address shortage

Scott Gottlieb
Scott Gottlieb

The FDA announced that it has approved a generic version of valsartan for the treatment of patients with high BP and HF.

The drug application for the generic version of valsartan (Diovan, Alkem Laboratories Limited) was prioritized by the FDA in light of the recalls of other generic versions of valsartan, according to a press release from the FDA.

As Cardiology Today previously reported, the initial recalls were due to an impurity, N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen based on laboratory test results. The presence of NDMA was unexpected and is believed to be related to changes in the way the active substance was manufactured.

“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,” Scott Gottlieb, MD, commissioner of the FDA, said in the press release. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”

During the approval process of this medication, the FDA assessed the manufacturing processes of the company and the testing methods used to detect NDMA and other impurities.

“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,” Gottlieb said in the press release. “We’ll continue to work with manufacturers so that more medicines like valsartan, that belong to a class of drugs called angiotensin II receptor blockers, can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage.”

Disclosure: Gottlieb is commissioner of the FDA.

Scott Gottlieb
Scott Gottlieb

The FDA announced that it has approved a generic version of valsartan for the treatment of patients with high BP and HF.

The drug application for the generic version of valsartan (Diovan, Alkem Laboratories Limited) was prioritized by the FDA in light of the recalls of other generic versions of valsartan, according to a press release from the FDA.

As Cardiology Today previously reported, the initial recalls were due to an impurity, N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen based on laboratory test results. The presence of NDMA was unexpected and is believed to be related to changes in the way the active substance was manufactured.

“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,” Scott Gottlieb, MD, commissioner of the FDA, said in the press release. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”

During the approval process of this medication, the FDA assessed the manufacturing processes of the company and the testing methods used to detect NDMA and other impurities.

“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,” Gottlieb said in the press release. “We’ll continue to work with manufacturers so that more medicines like valsartan, that belong to a class of drugs called angiotensin II receptor blockers, can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage.”

Disclosure: Gottlieb is commissioner of the FDA.