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    Tag: usfda

    You Searched For "usfda"
    Granules receives USFDA nod for  Potassium Chloride Extended-Release Tablets USP

    Granules receives USFDA nod for Potassium Chloride Extended-Release Tablets USP

    Medical Dialogues Bureau7 March 2020 10:00 AM IST
    Potassium Chloride ER Tablets are used for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom...
    USFDA accepts regulatory submission for tanezumab for management of chronic pain  due to osteoarthritis

    USFDA accepts regulatory submission for tanezumab for management of chronic pain due to osteoarthritis

    Medical Dialogues Bureau7 March 2020 10:00 AM IST
    Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF)...
    Alembic  Pharma bags USFDA nod for doxycycline hyclate tablets

    Alembic Pharma bags USFDA nod for doxycycline hyclate tablets

    MD bureau6 March 2020 9:15 AM IST
    Doxycycline hyclate tablets 20 mg have an estimated market size of USD 7 million for the 12-month period ending December 2019
    Valisure Detects High Levels of NDMA in Metformin

    Valisure Detects High Levels of NDMA in Metformin

    Medical Dialogues Bureau5 March 2020 9:00 AM IST
    FDA currently recognizes the danger of this compound and, as a result, has set strict daily acceptable intake limits and advised companies to recall...
    Sanofi gets USFDA nod for Sarclisa (isatuximab-irfc) for refractory multiple myeloma

    Sanofi gets USFDA nod for Sarclisa (isatuximab-irfc) for refractory multiple myeloma

    Medical Dialogues Bureau4 March 2020 12:11 PM IST
    Sarclisa offers an intravenous (IV) administration and is dosed at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two...
    Strides get USFDA nod for Tetracycline Hydrochloride Capsules

    Strides get USFDA nod for Tetracycline Hydrochloride Capsules

    Medical Dialogues Bureau4 March 2020 9:30 AM IST
    Tetracycline Hydrochloride Capsule is an antibiotic used to treat many different bacterial infections of the skin, intestines, respiratory tract,...
    Novartis updates on uses and safety of Beovu in patients with wet AMD

    Novartis updates on uses and safety of Beovu in patients with wet AMD

    Medical Dialogues Bureau3 March 2020 10:00 AM IST
    If clinical signs of intraocular inflammation or changes in vision after Beovu injection are observed doctor should perform the appropriate diagnostic...
    COVID-19: USFDA updates about supply chain effect on medicines, devices and PPE

    COVID-19: USFDA updates about supply chain effect on medicines, devices and PPE

    Medical Dialogues Bureau1 March 2020 2:45 PM IST
    A manufacturer has alerted that a shortage of a human drug that was recently added to the drug shortages list.
    FDA Advisory approves Lillys CYRAMZA (ramucirumab) for type of lung Cancer

    FDA Advisory approves Lilly's CYRAMZA (ramucirumab) for type of lung Cancer

    Medical Dialogues Bureau1 March 2020 2:00 PM IST
    The ODAC considered the safety and efficacy data from the Phase 3 RELAY trial, which is the basis for the CYRAMZA supplemental Biologics License...
    Biohaven Receives Fda Approval for acute migraine drug

    Biohaven Receives Fda Approval for acute migraine drug

    Medical Dialogues Bureau1 March 2020 12:30 PM IST
    A single quick-dissolving tablet of NURTEC ODT can provide fast pain relief and return patients to normal function within one hour, and deliver...
    Dr Reddys Laboratories launches generic of Naproxen, Esomeprazole Magnesium Delayed-Release Tablets

    Dr Reddy's Laboratories launches generic of Naproxen, Esomeprazole Magnesium Delayed-Release Tablets

    Medical Dialogues Bureau29 Feb 2020 1:30 PM IST
    Dr Reddy's Naproxen and Esomeprazole Magnesium Delayed-Release Tablets are available in 375 mg/20 mg and 500 mg/20 mg tablets in bottle count sizes of...
    Biocon Small Molecules API Manufacturing Facility Completes Post -Approval and GMP USFDA Inspection

    Biocon Small Molecules API Manufacturing Facility Completes Post -Approval and GMP USFDA Inspection

    Medical Dialogues Bureau29 Feb 2020 11:35 AM IST
    New Delhi: Drug API maker, Biocon has informed that the U.S. Food and Drug Administration (FDA) conducted a Post-Approval and GMP inspection of Small...
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