FDA approves new generic valsartan to reduce the shortage of drug

The regulator reviewed the manufacturing and testing practices of India-based Alkem Laboratories Limited and found no traces of impurity

The United States Food and Drug Administration (FDA) has reportedly announced to have approved a new generic version of valsartan to reduce the recent shortage of the medicine. As per trusted sources, the drug is primarily utilized to treat high blood pressure.

Reportedly, the FDA has issued several recalls of the generic version of valsartan drug since last summer from numerous manufacturers after it found nitrosamine impurities which pose a cancer risk to patients. It is being said that the regulator discovered impurities in only the generic version and not the brand name valsartan.

Commissioner of the FDA, Dr. Scott Gottlieb was reportedly quoted saying that the agency is aware of the ongoing recalls to stop specific batches of valsartan containing non-acceptable limits of impurities from reaching patients has led to a shortage of the important medicines. The FDA prioritized review of the newly approved generic version of valsartan to address the shortage, Gottlieb.

He also claimed that the approval would assist in reducing the shortage of valsartan and that the agency would remain committed to implement measures to avert the formation of the impurities during drug production procedures for existing and new products. Reportedly, the FDA would also work with pharmaceutical firms to ensure other similar blood pressure drugs, part of a type of drugs known as angiotension II receptor blockers, or ARBs, are available to customers.

According to the report by USA Today, the FDA reviewed the manufacturing and testing practices of India-based Alkem Laboratories Limited to ascertain whether its valsartan contains impurities found in the recalled blood pressure drugs of its rivals.

Reportedly, Alkem Laboratories is yet to reveal whether it plans to sell the drug in the United States.