Online pharmacy flags possible new impurity in blood pressure drug [Reuters (UK)]
Novartis AG (NVS)
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Source: Reuters
Online pharmacy flags possible new impurity in blood pressure drug - Reuters 3 Min Read (Reuters) - Online pharmacy Valisure reported that it found a new cancer-causing impurity in some versions of widely prescribed blood pressure medicine valsartan, but U.S. regulators said on Tuesday that the amount in the drugs was well below levels deemed to be potentially harmful. Connecticut-based Valisure informed the U.S. Food and Drug Administration in a citizen petiti here last week that it had found through its own testing an impurity called dimethylformamide (DMF) in some batches of the drug. DMF is classified as a probable human carcinogen by the World Health Organization. The findings were first reported by Bloomberg earlier on Tuesday. The FDA said it would review the petition, but “it is important to note that the amounts of DMF being reported are more than 100 times less than those determined by international standards as the level of concern to patients.” Valisure analyzed valsartan
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NVS
Earnings
- 4/23/24 - Beat
NVS
Sec Filings
- 4/23/24 - Form 6-K
- 2/15/24 - Form S-8
- 2/2/24 - Form SC
- NVS's page on the SEC website