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    Tag: fda

    You Searched For "FDA"
    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...
    Novartis signs deal with Gan & Lee as US government seeks to slash insulin cost

    Novartis signs deal with Gan & Lee as US government seeks to slash insulin cost

    Medical Dialogues Bureau30 Dec 2018 9:20 AM IST
    ZURICH: Swiss drugmaker Novartis aims to become a big player in supplying insulin to swelling numbers of diabetics, signing a deal with China's Gan...
    Another trouble for J&J: CDSCO seize samples of baby products for testing

    Another trouble for J&J: CDSCO seize samples of baby products for testing

    Farhat Nasim22 Dec 2018 12:14 PM IST
    The action by CDSCO has come at a time when the company is already embroiled in a controversy over its faulty hip implants. New Delhi: Following...
    Asbestos scare: CDSCO draws samples of J&J baby powder from HP plant

    Asbestos scare: CDSCO draws samples of J&J baby powder from HP plant

    Medical Dialogues Bureau20 Dec 2018 5:12 PM IST
    The CDSCO, under the Union Health Ministry, said over the next four to five days, drug inspectors will search manufacturing plants and wholesalers of...
    US FDA to strictly monitor sale of flavoured e-cigarettes

    US FDA to strictly monitor sale of flavoured e-cigarettes

    Medical Dialogues Bureau10 Nov 2018 3:46 PM IST
    The new policy will apply to flavoured cartridge-style vaping products like Juul that have become popular among youths, not the open tank-style...
    FDA grants priority review for Sanofi

    FDA grants priority review for Sanofi's dengue vaccine candidate

    Medical Dialogues Bureau4 Nov 2018 11:00 AM IST
    The vaccine, known as Dengvaxia in countries where it is approved, remains the only vaccine available for the prevention of dengue. The European...
    FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

    FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

    Medical Dialogues Bureau4 Nov 2018 9:36 AM IST
    New Delhi: The U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during...
    SGLT2 inhibitors can lead to serious genital infection: USFDA warning

    SGLT2 inhibitors can lead to serious genital infection: USFDA warning

    Ruby Khatun Khatun31 Aug 2018 4:50 PM IST
    The SGLT2 inhibitors approved by the FDA include Johnson and Johnson's Invokana, Eli Lilly & Co's Jardiance, as well as those from Bristol-Myers...
    FDA declines to approve Allergan

    FDA declines to approve Allergan's Esmya

    Medical Dialogues Bureau24 Aug 2018 9:45 AM IST
    Allergan Plc said U.S. health regulators had declined to approve Esmya, its treatment for abnormal uterine bleeding in women with uterine fibroids,...
    Unichem Labs gets 4 observations from USFDA for Roha facility

    Unichem Labs gets 4 observations from USFDA for Roha facility

    Ruby Khatun Khatun8 Aug 2018 10:30 AM IST
    New Delhi: Drug firm Unichem Laboratories said the US health regulator has made four observations after inspection of its active pharmaceutical...
    GSK

    GSK's severe pediatric asthma drug wins European panel thumbs-up

    Ruby Khatun Khatun30 July 2018 10:00 AM IST
    GlaxoSmithKline (GSK) drug Nucala has won a key recommendation from a European Medicines Agency (EMA) panel for use in the treatment of children with...
    Stronger Warning for fluoroquinolone antibiotics added by FDA

    Stronger Warning for fluoroquinolone antibiotics added by FDA

    Ruby Khatun Khatun15 July 2018 11:45 AM IST
    FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox),...
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