Hypertension drug recall by USFDA shot in the arm for some drug majors The recall was due to an impurity (N-Nitrosodimethylamine or NDMA) which was found in the recalled products that include valsartan and its combinations
The recent recall of a common hypertension drug in the US due to contamination with a carcinogen has opened up short-term opportunities for a handful of Indian players. The issue with sartan (hypertension drug) began around July, when the US Food and Drug Administration (USFDA) notified health care professionals of a voluntary recall of several drug products containing the active ingredient valsartan. Valsartan is used to treat high blood pressure and heart failure. The recall was due to an impurity (N-Nitrosodimethylamine or NDMA) which was found in the recalled products that include valsartan and its combinations. According to the USFDA’s list of products under recall, four companies - Teva, Prinston, Torrent, and Hetero - have recalled products containing the valsartan active ingredient. The USFDA also placed primary Chinese supplier Zhejiang Huahai Pharmaceutical on import alert. The European Medicines Agency also withdrew the authorisation for the Chinese valsartan product maker. Read More