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    Tag: fda

    You Searched For "fda"
    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 3:57 AM GMT
    The U.S. Food and Drug Administration granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a...
    Setback: USFDA rejects Sanofi, Lexicon Sotagliflozin for type 1 diabetes

    Setback: USFDA rejects Sanofi, Lexicon Sotagliflozin for type 1 diabetes

    Farhat Nasim24 March 2019 4:15 AM GMT
    The decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin, shoul...
    USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths

    USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths

    Farhat Nasim21 March 2019 4:15 AM GMT
    The clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukaemia (CLL) or acute myeloid leukaemia...
    USFDA accepts Allergan license applications to expand Botox label

    USFDA accepts Allergan license applications to expand Botox label

    Farhat Nasim11 March 2019 4:00 AM GMT
    'The FDA's acceptance of Allergan's supplemental biologics license applications is a monumental milestone on our journey to bring new treatment options...
    J&J passes asbestos test, allowed to make baby powder in India

    J&J passes asbestos test, allowed to make baby powder in India

    Farhat Nasim1 March 2019 8:58 AM GMT
    NEW DELHI: In a major relief to Johnson & Johnson(J&J), no asbestos was found in the baby powder manufactured in Baddi and Mulund plants. The...
    Lupin gets USFDA nod to Methylprednisolone tablets to treat inflammation

    Lupin gets USFDA nod to Methylprednisolone tablets to treat inflammation

    Farhat Nasim26 Feb 2019 4:20 AM GMT
    The company has received approval from the US Food and Drug Administration (USFDA) to market Methylprednisolone tablets, a generic version of Pharmacia...
    Mylan launches Advair generic at 70 percent discount in US

    Mylan launches Advair generic at 70 percent discount in US

    Farhat Nasim14 Feb 2019 3:45 AM GMT
    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...
    Pfizer says USFDA accepts regulatory submissions for review of tafamidis

    Pfizer says USFDA accepts regulatory submissions for review of tafamidis

    Medical Dialogues Bureau16 Jan 2019 4:05 AM GMT
    Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial ...
    Health Canada places restrictions on Allergan Fibroid treatment Esmya

    Health Canada places restrictions on Allergan Fibroid treatment Esmya

    Farhat Nasim13 Jan 2019 3:30 AM GMT
    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 6:40 AM GMT
    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 4:15 AM GMT
    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 Tabl...
    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 3:50 AM GMT
    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...
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