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India’s Hetero pulls heart drug from U.S.

Written by: | no-reply@reuters.com | Dated: Saturday, August 11th, 2018

 

India’s Hetero pulls heart drug from U.S. amid cancer risk probes

 

MUMBAI (Reuters) – A unit of India’s Hetero Drugs is recalling some batches of the blood pressure and heart medicine valsartan in the United States, a notice on the U.S. regulator’s website said, amid a wider probe into cancer risks associated with the drug.

At least a dozen companies around the world have pulled specific batches of valsartan from the market since early July, when regulators said valsartan made by the Chinese supplier Zhejiang Huahai Pharmaceuticals had been found to contain a probable human carcinogen, N-nitrosodimethylamine (NDMA).

The notice from the U.S. Food and Drug Administration (FDA) said Hetero was found to be using a similar manufacturing process to China’s Zhejiang Huahai for valsartan. (bit.ly/2MjohkN)

“Test results from Hetero Labs show the amount of NDMA found in its valsartan active pharmaceutical ingredient (API) exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang,” the FDA said.

Hetero declined to comment, a spokesman in India said.

The company, among India’s top 15 drugmakers and one of the world’s largest suppliers of HIV/AIDS drugs, sells valsartan in the United States through its unit Camber Pharmaceuticals, which is recalling the drug as a “precautionary measure,” the FDA notice said.

It added that Camber had not received any reports of adverse events related to the drug. (bit.ly/2Bc5u6T)

Calls to New Jersey-based Camber went unanswered on Saturday, outside of regular working hours.

 

INDIA IMPORTS

Valsartan was originally developed by the Swiss firm Novartis and sold under the name Diovan, but it is now off patent and is used in several generic medicines made by companies around the world.

Hetero’s website says the company has more than 30 manufacturing plants around the world.

 

Reuters source:

https://www.reuters.com/article/us-india-hetero-recall/indias-hetero-pulls-heart-drug-from-u-s-amid-cancer-risk-probes-idUSKBN1KW05Q

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