FDA approve valsartan generic after shortages of supply
pharmafile | March 13, 2019 | News story | Manufacturing and Production, Research and Development | FDA, blood pressure drugs, cardiovascular, generic, valsartan
The FDA has approved a new generic version of blood pressure drug valsartan. The approval comes amid shortages in supply after recalls were made in reaction to the discovery of impurities.The generic version will be produced by Mumbai-based firm Alkem Laboratories Limited.
The F.D.A. prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers,” the agency said in a statement.
The approval comes after the FDA began to recall valsartan products in July of last year. The US regulator enacted the recall after discovering the heart drugs had been contaminated with potential carcinogen N-nitrosodimethylamine, or NDMA.
The recalls subsequently led to shortages which were in turn jumped upon by price hiking firms who sort to take advantage of the situation.
Major Pharmaceuticals, Teva Pharmaceutical Industries, and Solco Healthcare, which is owned by Huahai Pharmaceutical, were responsible for distributing Valsartan in the United States.
“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,” said FDA Commissioner Scott Gottlieb, M.D. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”
Louis Goss
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