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    Tag: usfda

    You Searched For "usfda"
    Laurus Labs gets tentative USFDA approval for HIV combo drug

    Laurus Labs gets tentative USFDA approval for HIV combo drug

    Farhat Nasim4 Feb 2019 9:30 AM IST
    Hyderabad: Indian pharmaceutical player, Laurus Labs said Sunday it has received tentative approval from the United States Food and Drug...
    Novartis Kymriah wins UK backing after initial lymphoma snub

    Novartis Kymriah wins UK backing after initial lymphoma snub

    Medical Dialogues Bureau3 Feb 2019 10:00 AM IST
    "Today's positive announcement regarding access to Kymriah treatment in England and Wales was secured as a result of our close working collaboration...
    Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets

    Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets

    Medical Dialogues Bureau24 Jan 2019 9:30 AM IST
    Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration for Abiraterone Acetate tablets...
    Dr Reddy

    Dr Reddy's gets four observations from USFDA for Andhra plant

    Medical Dialogues Bureau19 Jan 2019 9:30 AM IST
    "The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today....
    Health Canada places restrictions on Allergan Fibroid treatment Esmya

    Health Canada places restrictions on Allergan Fibroid treatment Esmya

    Farhat Nasim13 Jan 2019 9:00 AM IST
    The drug is sold in Europe by Hungarian drugmaker Richter. Richter has said it considered Esmya to be a safe and effective form of treatment.Canada:...
    Lupin gets USFDA nod for generic schizophrenia drug

    Lupin gets USFDA nod for generic schizophrenia drug

    Medical Dialogues Bureau8 Jan 2019 12:10 PM IST
    New Delhi: Drug maker Lupin Monday said it has received approval from the US health regulator to market Lurasidone Hydrochloride tablets, used in the...
    Lupin receives FDA approval for Lurasidone Hydrochloride Tablets

    Lupin receives FDA approval for Lurasidone Hydrochloride Tablets

    Farhat Nasim7 Jan 2019 9:45 AM IST
    Lupin's Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg is the generic version of Sunovion Pharmaceuticals, Inc's Latuda...
    Lupin receives FDA approval for Clobazam Oral Suspension

    Lupin receives FDA approval for Clobazam Oral Suspension

    Farhat Nasim1 Jan 2019 10:00 AM IST
    Lupin's Clobazam Oral Suspension, 2.5 mg/mL is the generic version of Lundbeck Pharmaceuticals, LLC's Onfi Oral Suspension, 2.5 mg/mL. It is indicated...
    After damaging Reuters report, J&J doubles down on talc safety message

    After damaging Reuters report, J&J doubles down on talc safety message

    Farhat Nasim1 Jan 2019 9:15 AM IST
    To reassure investors and consumers, J&J has tweeted, posted on Facebook, run a series of full-page newspaper ads across the United States,...
    Cadila Healthcare arm gets USFDA nod to market Ranitidine injection

    Cadila Healthcare arm gets USFDA nod to market Ranitidine injection

    Medical Dialogues Bureau12 Dec 2018 10:00 AM IST
    NEW DELHI: Drug firm Cadila Healthcare on Tuesday said its subsidiary has received approval from the US health regulator to market Ranitidine...
    Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution

    Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution

    Medical Dialogues Bureau10 Dec 2018 9:15 AM IST
    New Delhi: Drug firm Alembic Pharma on Monday said it has received approval from the US health regulator for Olopatadine Hydrochloride ophthalmic...
    IMPLANT FILES IMPACT: USFDA plans overhaul of decades-old medical device system

    IMPLANT FILES IMPACT: USFDA plans overhaul of decades-old medical device system

    Medical Dialogues Bureau28 Nov 2018 4:15 PM IST
    New Delhi: US health officials said Monday they plan to overhaul the nation's decades-old medical device system for approving most medical devices,...
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