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    Tag: u.s. food and drug administration

    You Searched For "US Food and Drug Administration"
    USFDA nod to Teva generic nasal spray-Narcan to treat opioid overdose

    USFDA nod to Teva generic nasal spray-Narcan to treat opioid overdose

    Medical Dialogues Bureau21 April 2019 9:27 AM IST
    The U.S. Food and Drug Administration granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a...
    Sun Pharma launches cancer drug INFUGEM in US market

    Sun Pharma launches cancer drug INFUGEM in US market

    Farhat Nasim9 April 2019 10:05 AM IST
    Sun Pharma said INFUGEM uses its proprietary technology which allows cytotoxic oncology products to be premixed in a sterile environment and supplied...
    GSK gets USFDA nod for HIV-1 drug branded as Dovato

    GSK gets USFDA nod for HIV-1 drug branded as Dovato

    Farhat Nasim9 April 2019 9:20 AM IST
    GSK already has two-drug regimen Juluca on the market, but only for the smaller market of HIV patients that have received prior treatment. Dovato is...
    Lupin, Aurobindo Pharma recalls multiple lots of BP drug including VALSARTAN

    Lupin, Aurobindo Pharma recalls multiple lots of BP drug including VALSARTAN

    Farhat Nasim1 April 2019 9:50 AM IST
    Aurobindo Pharma is also recalling certain lots of Amlodipine and Valsartan Tablets USP 10mg/160mg in 30 count bottles for CGMP deviations.New Delhi:...
    Lupin Somerset facility gets OAI letter from USFDA

    Lupin Somerset facility gets OAI letter from USFDA

    Farhat Nasim18 March 2019 9:25 AM IST
    "The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending...
    USFDA Caution: Lupin gets OAI letter for MP plant

    USFDA Caution: Lupin gets OAI letter for MP plant

    Medical Dialogues Bureau17 March 2019 9:45 AM IST
    Lupin has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Mandideep (Unit 1) facility...
    OxyContin maker Purdue Pharma exploring bankruptcy: Report

    OxyContin maker Purdue Pharma exploring bankruptcy: Report

    Farhat Nasim5 March 2019 9:20 AM IST
    Sales of OxyContin and other opioids have fallen amid public concern about their addictive nature, and as restrictions on opioid prescribing have been...
    Shilpa Medicare gets USFDA nod for Gemcitabine to treat types of cancer

    Shilpa Medicare gets USFDA nod for Gemcitabine to treat types of cancer

    Farhat Nasim27 Feb 2019 9:30 AM IST
    The company has received US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA), Gemcitabine for injection...
    Alembic Pharma gets USFDA nod for Acetazolamide extended release capsules

    Alembic Pharma gets USFDA nod for Acetazolamide extended release capsules

    Farhat Nasim21 Feb 2019 9:45 AM IST
    Acetazolamide extended-release capsule is therapeutically equivalent to the reference listed drug, Diamox Sequels, 500 mg, of Teva Branded...
    Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution

    Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution

    Farhat Nasim17 Feb 2019 9:30 AM IST
    The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Olopatadine...
    Supreme Court refuses interim order on sale of Fortis shares to IHH; final hearing on February 26

    Supreme Court refuses interim order on sale of Fortis shares to IHH; final hearing on February 26

    Medical Dialogues Bureau16 Feb 2019 12:33 PM IST
    A bench comprising Chief Justice Ranjan Gogoi and Justice Sanjiv Khanna said that it would accord final hearing in the case on February 26.New Delhi:...
    Mylan launches Advair generic at 70 percent discount in US

    Mylan launches Advair generic at 70 percent discount in US

    Farhat Nasim14 Feb 2019 9:15 AM IST
    The treatment, the first generic of Advair, is approved in three doses and will be priced between $93.71 and $153.14, the company said.U.S: Mylan NV...
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