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    USFDA temporarily allows sale of certain BP medicines amid shortage

    Farhat NasimWritten by Farhat Nasim Published On 2019-03-22T09:00:19+05:30  |  Updated On 22 March 2019 9:00 AM IST
    USFDA temporarily allows sale of certain BP medicines amid shortage

    Some generic versions of other ARBs such as valsartan and irbesartan have also been recalled and the agency in January warned of the possibility of additional shortages of the widely used drugs in the United States. The products are used to treat BP.


    U.S: The U.S. Food and Drug Administration on Wednesday said it will temporarily allow certain manufacturers to sell blood pressure medications containing specified levels of a probable cancer-causing impurity in order to maintain adequate supplies of the drug.


    The agency said losartan medicines remaining on the market that contain the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable limit of 0.96 parts per million (ppm) and below 9.82 ppm will be allowed until the impurity can be eliminated.


    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 losartan.


    Some generic versions of other ARBs such as valsartan and irbesartan have also been recalled, and the agency in January warned of the possibility of additional shortages of the widely used drugs in the United States.


    Also Read: Vaslartan Recall: DCGI to launch probe as China co recalls BP drug


    Last week, the FDA approved a new generic version of valsartan to ease the shortages triggered by several manufacturers recalling the drug over possible cancer risk.


    The FDA on Wednesday said it expects companies to be able to manufacture losartan without the probable carcinogen and replenish supplies in the United States in about six months.


    Agency scientists have found that exposure to the NMBA impurity within specified levels present no meaningful difference in cancer risk over a six-month time period when compared to a lifetime of exposure, the FDA said in an update on its website.


    Global authorities have clamped down on sales of some of these hypertension medicines, leading to drugmakers such as Teva Pharmaceutical Industries Ltd and Mylan NV pulling batches of the drugs that have been found to contain probable carcinogens.


    Also Read: Valsartan Shortage: Alkem Labs gets USFDA nod to generic Diovan

    blood pressureBPBP medicinecancercancer-causingcarcinogendrugdrug shortageEstrogen receptorFDAgenericgenericshealthhealth newsHealth news IndiahypertensionimpuritiesLosartanmedicalmedicinemedicinesMylanpharmapharma newspharma news indiaSibiTeva Pharmaceutical IndustriesUSUSFDAValsartan
    Source : Reuters

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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