FDA Approves Generic Valsartan Amid Drug Shortage

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration said on Tuesday it had approved a new generic version of blood pressure medicine valsartan, as the agency looks to ease shortages triggered by several manufacturers recalling the drug over possible cancer risk.

Drugmakers, including Teva Pharmaceutical Industries Ltd and Mylan NV, have pulled batches of valsartan from market as the drugs have been found to contain probable carcinogens.

The FDA said it had sped up the review of the generic from India's Alkem Laboratories Ltd before its approval.

"When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients," outgoing FDA Commissioner Scott Gottlieb said in a statement.

"To address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products."

In January, the FDA warned of the possibility of additional shortages of hypertension drugs in the United States due to the recalls.

Since last summer, the FDA has been conducting a major investigation to address the presence of certain impurities in a class of drugs called angiotensin II receptor blockers (ARBs), including valsartan.

Some generic versions of other ARBS such as losartan and irbesartan have also been recalled.

Global authorities have also clamped down on sales of some of these medicines as they are suspected to be tainted with probable carcinogens N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA).

The recalls began last year after regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co to produce valsartan contained cancer-causing impurities.

On Tuesday, the FDA said it had evaluated Alkem's manufacturing processes and made sure the company used appropriate testing methods to demonstrate that the valsartan approved - a generic to Novartis' Diovan - did not contain NDMA or NDEA.

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