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    Tag: usfda

    You Searched For "usfda"
    Eli Lilly new migraine drug Emgality pulls ahead of Amgen in battle for prescriptions

    Eli Lilly new migraine drug Emgality pulls ahead of Amgen in battle for prescriptions

    Farhat Nasim12 May 2019 9:30 AM IST
    Weekly U.S. prescription data from IQVIA, an analytics provider to the life sciences industry, showed that Lilly's therapy Emgality claimed the...
    Unichem Labs gets tentative USFDA nod for generic version of JnJ Zyrtec-D 12 Hour

    Unichem Labs gets tentative USFDA nod for generic version of JnJ Zyrtec-D 12 Hour

    Farhat Nasim9 May 2019 10:15 AM IST
    Unichem Lab's approved drug is a generic copy of Zyrtec-D 12 Hour which is used for treating allergic rhinitis.New Delhi: Unichem Laboratories Tuesday...
    Natco Pharma marketing partner gets USFDA approval for Nitroglycerin Sublingual Tablets

    Natco Pharma marketing partner gets USFDA approval for Nitroglycerin Sublingual Tablets

    Farhat Nasim8 May 2019 10:15 AM IST
    Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood...
    Pfizer gets USFDA nod for potential blockbuster heart drug Tafamidis

    Pfizer gets USFDA nod for potential blockbuster heart drug Tafamidis

    Medical Dialogues Bureau7 May 2019 9:45 AM IST
    Pfizer, which has touted tafamidis as a potential blockbuster product, set a list price of $225,000 a year for the medicine, which would be sold under...
    Jacobus Pharma wins USFDA approval for Ruzurgi to treat rare autoimmune disorder

    Jacobus Pharma wins USFDA approval for Ruzurgi to treat rare autoimmune disorder

    Medical Dialogues Bureau7 May 2019 9:25 AM IST
    The drug, Ruzurgi, was approved for use in patients aged between 6 and 17, the FDA said Lambert-Eaton myasthenic syndrome, which affects about three...
    Lupin, Zydus Cadila recall products in US; includes BP drug Carvedilol

    Lupin, Zydus Cadila recall products in US; includes BP drug Carvedilol

    Farhat Nasim6 May 2019 10:00 AM IST
    Lupin Somerset is recalling 46,700 bottles of Morphine Sulfate extended-release tablets in various strengths due to "failed impurities/degradation...
    Cadila Healthcare gets 14 USFDA observations for Moraiya plant

    Cadila Healthcare gets 14 USFDA observations for Moraiya plant

    Farhat Nasim4 May 2019 10:00 AM IST
    The US Food and Drug Administration (USFDA) inspected the plant from April 22, 2019 to May 3, 2019, Cadila Healthcare said in a regulatory filing.New...
    AbbVie wins USFDA nod for Mavyret to treat HCV genotypes in pediatric patients

    AbbVie wins USFDA nod for Mavyret to treat HCV genotypes in pediatric patients

    Farhat Nasim3 May 2019 9:10 AM IST
    New Delhi: AbbVie Inc. recently won the U.S. Food and Drug Administration (USFDA) approval for Mavyret (glecaprevir and pibrentasvir) tablets to treat...
    Alembic Pharma gets USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution

    Alembic Pharma gets USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution

    Farhat Nasim2 May 2019 4:04 PM IST
    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.New...
    Sanofi wins USFDA approval to sell dengue vaccine Dengvaxia in parts of US

    Sanofi wins USFDA approval to sell dengue vaccine Dengvaxia in parts of US

    Farhat Nasim2 May 2019 10:00 AM IST
    Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots...
    Zydus Cadila gets USFDA nod to market 2 generic drugs

    Zydus Cadila gets USFDA nod to market 2 generic drugs

    Medical Dialogues Bureau1 May 2019 8:05 PM IST
    New Delhi: Drug firm Zydus Cadila Tuesday said it has received the final nod from the USFDA to market generic Bosentan tablets and Trientine...
    Cipla gets USFDA nod for Ambrisentan tablets to treat pulmonary arterial hypertension

    Cipla gets USFDA nod for Ambrisentan tablets to treat pulmonary arterial hypertension

    Farhat Nasim30 April 2019 10:00 AM IST
    Cipla's Ambrisentan tablets 5 mg and 10 mg is AB-rated generic therapeutic equivalent version of Gilead Sciences Inc's Letairis.New Delhi: Drug major...
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