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    Tag: usfda

    You Searched For "usfda"
    Sun Pharma launches RIOMET ER diabetes drug in the US

    Sun Pharma launches RIOMET ER diabetes drug in the US

    Medical Dialogues Bureau27 Feb 2020 11:00 AM
    Riomet ER™, dosed once daily, is the first and only FDA-approved liquid formulation of extended-release metformin.
    USFDA inspection at Cipla manufacturing facility in Goa, warning letter issued

    USFDA inspection at Cipla manufacturing facility in Goa, warning letter issued

    Medical Dialogues Bureau27 Feb 2020 8:26 AM
    New Delhi: Drug firm Cipla recently announced that it has received a warning letter from USFDA for its goa Manufacturing Facility.Pursuant to...
    USFDA identifies 20 drugs with shortage risks due to coronavirus outbreak

    USFDA identifies 20 drugs with shortage risks due to coronavirus outbreak

    Medical Dialogues Bureau26 Feb 2020 10:24 AM
    NEW YORK - The U.S. Food and Drug Administration has contacted producers of about 20 drugs that either source all of their main ingredients from or...
    FDA authorizes marketing of the first genetic test for Fragile X Syndrome

    FDA authorizes marketing of the first genetic test for Fragile X Syndrome

    Medical Dialogues Bureau25 Feb 2020 8:39 AM
    US: The U.S. Food and Drug Administration has authorized marketing of the test to detect a genetic condition known as Fragile X Syndrome (FXS), the...
    Novartis announces FDA and EMA filing acceptance of ofatumumab, for treatment of relapsing form of MS

    Novartis announces FDA and EMA filing acceptance of ofatumumab, for treatment of relapsing form of MS

    Medical Dialogues Bureau25 Feb 2020 7:33 AM
    "With ofatumumab, we underpin our relentless dedication to reimagining medicine for patients across the MS spectrum and will work closely with the...
    Aurobindo Pharma gets USFDA nod for Azithromycin 250 mg and 500 mg

    Aurobindo Pharma gets USFDA nod for Azithromycin 250 mg and 500 mg

    Medical Dialogues Bureau24 Feb 2020 8:52 AM
    New Delhi: Drug firm Aurobindo Pharma has received final approval from the USFDA to manufacture and market Azithromycin tablets, used for the...
    Solara Puducherry and Mangalore facilities complete USFDA Inspection with zero 483s observations

    Solara Puducherry and Mangalore facilities complete USFDA Inspection with zero 483s observations

    Medical Dialogues Bureau24 Feb 2020 6:48 AM
    Chennai: Solara Active Pharma Science Limited (Solara), an active Pharmaceutical Ingredient provider has announced that the US Food and Drug...
    Biocons Insulin Manufacturing Facility in Malaysia Completes USFDA inspection with three observations

    Biocon's Insulin Manufacturing Facility in Malaysia Completes USFDA inspection with three observations

    Medical Dialogues Bureau24 Feb 2020 6:41 AM
    Malaysia:Drug major Biocon recently informed about the USFDA inspection at its Insulin Manufacturing Facility in Malaysia, and that the agency issued...
    USFDA approves Eli Lillys Trulicity (dulaglutide) for reduction in MACE in type 2 diabetes patient

    USFDA approves Eli Lilly's Trulicity (dulaglutide) for reduction in MACE in type 2 diabetes patient

    Medical Dialogues Bureau23 Feb 2020 6:30 AM
    New indication reflects a distinct patient population in the REWIND study, including primary people with multiple cardiovascular risk factors but...
    FDA approves Lundbecks intravenous migraine prevention drug Vyepti, to launch in April 2020

    FDA approves Lundbeck's intravenous migraine prevention drug Vyepti, to launch in April 2020

    Medical Dialogues Bureau23 Feb 2020 6:00 AM
    Deerfield: Lundbeck announced that VYEPTI™ (eptinezumab-jjmr) has been approved by the U.S. Food and Drug Administration (FDA) for the preventive...
    With USFDA approval in Hand, Esperion to launch Non-Statin Cholesterol drug NEXLETOL  for as low as 10 dollars

    With USFDA approval in Hand, Esperion to launch Non-Statin Cholesterol drug NEXLETOL for as low as 10 dollars

    Medical Dialogues Bureau22 Feb 2020 10:40 AM
    Eligible patients in the USA with commercial drug insurance coverage for NEXLETOL may pay as little as $10 per fill, up to a 3-month supply.
    Top Cos in pharmaceutical supply chain develop Blockchain system to track prescription drugs, stop counterfeit

    Top Cos in pharmaceutical supply chain develop Blockchain system to track prescription drugs, stop counterfeit

    Medical Dialogues Bureau22 Feb 2020 10:34 AM
    Among the 24 participating companies are Amgen Inc, FedEx Corp, GlaxoSmithKline Plc, Novartis, AmerisourceBergen Corp , Sanofi ), Walgreens Boots...
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