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  • Alembic Pharma gets final USFDA nod for generic formoterol fumarate inhalation solution Nov 23, 2021 01:52 PM IST

    Alembic Pharma gets final USFDA nod for generic formoterol fumarate inhalation solution

    The approval for the abbreviated new drug application (ANDA) for formoterol fumarate inhalation solution is for 20 mcg/2 ml per unit-dose vial.

  • Zydus Cadila gets USFDA nod to market generic cancer drug in US Nov 20, 2021 03:07 PM IST

    Zydus Cadila gets USFDA nod to market generic cancer drug in US

    The company has received final approval from the US Food and Drug Administration (USFDA) to Decitabine for Injection in the strength of 50 mg/vial single-dose vial, Zydus Cadila said in a statement.

  • Zydus Cadila gets USFDA nod for cancer drug with 180-days exclusivity Nov 18, 2021 02:48 PM IST

    Zydus Cadila gets USFDA nod for cancer drug with 180-days exclusivity

    The company has received approval from the US Food and Drug Administration (USFDA) for the Nelarabine injection 250 MG/50ML, a generic version of Arranon injection.

  • US FDA advisers back Pfizer/BioNTech COVID-19 vaccine for children Oct 27, 2021 08:01 AM IST

    US FDA advisers back Pfizer/BioNTech COVID-19 vaccine for children

    An authorization for that age group would be would be an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning.

  • US FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children Oct 26, 2021 06:30 PM IST

    US FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

    The advisers are expected to pay close attention to the rate of rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.

  • US authorizes 'mix and match' Covid vaccine boosters: Regulator Oct 21, 2021 11:56 AM IST

    US authorizes 'mix and match' Covid vaccine boosters: Regulator

    The Pfizer, Moderna, and Johnson & Johnson vaccines are authorized in the United States. A single dose of any of them may now be used following completion of primary vaccination with a different Covid vaccine.

  • US FDA to allow mixing and matching of COVID-19 boosters: Report Oct 19, 2021 03:53 PM IST

    US FDA to allow mixing and matching of COVID-19 boosters: Report

    The FDA in September authorized a booster dose of Pfizer Inc and partner BioNTech's two-shot COVID-19 vaccine for those aged 65 and older and some high-risk Americans.

  • Merck asks US regulators to authorize promising anti-COVID pill Oct 11, 2021 03:49 PM IST

    Merck asks US regulators to authorize promising anti-COVID pill

    Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs are used.

  • Caplin Point Lab's CRO arm completes USFDA audit with 'nil' observations Sep 24, 2021 02:20 PM IST

    Caplin Point Lab's CRO arm completes USFDA audit with 'nil' observations

    In a regulatory filing, Caplin Point Laboratories said Amaris Clinicals located at Chennai, has completed a virtual audit from United States Food and Drug Administration (USFDA) with ''nil'' observations.

  • Zydus Cadila unit gets USFDA nod for generic plaque psoriasis treatment drug Sep 24, 2021 02:12 PM IST

    Zydus Cadila unit gets USFDA nod for generic plaque psoriasis treatment drug

    The company's US-based subsidiary Zydus Pharmaceuticals (USA) Inc has received final approval from the US Food and Drug Administration (USFDA) to market Apremilast tablets in the strengths of 10 mg, 20 mg, 30 mg in the US market, Zydus Cadila said in a statement.

  • Glenmark gets USFDA nod for generic antibiotic cream Sep 21, 2021 12:27 PM IST

    Glenmark gets USFDA nod for generic antibiotic cream

    The Mumbai-based firm has received final approval from the US Food and Drug Administration (USFDA) to market Clindamycin Phosphate Foam (1 per cent) which is a generic version of Mylan Pharmaceuticals Inc's Evoclin Foam.

  • Zydus Cadila gets USFDA nod for schizophrenia treatment drug Sep 09, 2021 02:12 PM IST

    Zydus Cadila gets USFDA nod for schizophrenia treatment drug

    The company has received tentative approval from the US Food and Drug Administration (USFDA) to market Brexpiprazole tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the drug firm said in a statement.

  • Zydus Cadila gets USFDA nod for diabetes medication Sep 06, 2021 12:48 PM IST

    Zydus Cadila gets USFDA nod for diabetes medication

    The company said its subsidiary has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets.

  • Aurobindo Pharma gets USFDA nod for cancer treatment injection Aug 27, 2021 01:39 PM IST

    Aurobindo Pharma gets USFDA nod for cancer treatment injection

    The company’s subsidiary "Eugia Pharma Specialities Ltd has received a 505(b)(2) NDA approval from the US Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vial,” Aurobindo Pharma said in a regulatory filing.

  • Fauci expects uptick after FDA OKs Pfizer shot Aug 24, 2021 08:02 PM IST

    Fauci expects uptick after FDA OKs Pfizer shot

    The top infectious disease expert in the US says the Food and Drug Administration’s decision Monday should encourage people who cited lack of approval as a reason for not getting vaccinated.

  • Pfizer submits initial data for COVID-19 vaccine booster authorization Aug 17, 2021 07:58 AM IST

    Pfizer submits initial data for COVID-19 vaccine booster authorization

    They said the third dose showed significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus compared to the two doses as well as against the Beta and the highly infectious Delta variants.

  • IPCA Labs: Strong revival for domestic formulations Aug 09, 2021 11:25 AM IST

    IPCA Labs: Strong revival for domestic formulations

    IPCA, which was mainly known a few years ago for anti-malarial medications, is now having a significant contribution from non-anti-malarial medicines

  • Alembic Pharma gets final approval from USFDA for OCD treatment drug Aug 05, 2021 02:14 PM IST

    Alembic Pharma gets final approval from USFDA for OCD treatment drug

    The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Clomipramine Hydrochloride Capsules USP in the strengths 25 mg, 50 mg, and 75 mg, Alembic Pharmaceuticals said in a regulatory filing.

  • FDA adds warning about rare reaction to J&J COVID-19 vaccine Jul 22, 2021 11:04 PM IST

    FDA adds warning about rare reaction to J&J COVID-19 vaccine

    Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that typically is temporary.

  • Biogen Alzheimer's drug slow to take off as US Medicare wrestles with coverage Jul 21, 2021 05:45 PM IST

    Biogen Alzheimer's drug slow to take off as US Medicare wrestles with coverage

    Experts say Medicare could seek to lower the therapy's cost to taxpayers by limiting access to the treatment, linking coverage to real-world evidence of patient outcomes, or setting a fixed payment that combines drug reimbursement with other costs related to the treatment.

  • Alembic Pharma gets USFDA nod for cancer treatment drug Jul 09, 2021 12:23 PM IST

    Alembic Pharma gets USFDA nod for cancer treatment drug

    The approved product is therapeutically equivalent to the reference listed drug product Tarceva tablets of OSI Pharmaceuticals, LLC.

  • Zydus Cadila gets USFDA nod to market generic HIV infection treatment tablets Jul 02, 2021 02:49 PM IST

    Zydus Cadila gets USFDA nod to market generic HIV infection treatment tablets

    The company has received final approval from the United States Food and Drug Administration (USFDA) to market Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 100 mg/150 mg, 133 mg/200 mg and 167 mg/250 mg, Zydus Cadila said in a statement.

  • Alembic Pharma gets USFDA nod for generic Nitrofurantoin capsules Jul 01, 2021 02:07 PM IST

    Alembic Pharma gets USFDA nod for generic Nitrofurantoin capsules

    The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Nitrofurantoin capsules, USP in the strengths of 25 mg, 50 mg and 100 mg, Alembic Pharma said in a regulatory filing.

  • USFDA warning letter to Lupin on Somerset facility cites repeated GMP violations at manufacturing network Jun 30, 2021 10:14 AM IST

    USFDA warning letter to Lupin on Somerset facility cites repeated GMP violations at manufacturing network

    "Repeated violations at multiple sites demonstrate your company’s corporate oversight and control over the manufacture of drugs is inadequate," the USFDA said in the letter addressed to Vinita Gupta, CEO of Lupin

  • FDA adds warning about rare heart inflammation to Pfizer, Moderna COVID shots Jun 26, 2021 11:26 AM IST

    FDA adds warning about rare heart inflammation to Pfizer, Moderna COVID shots

    For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said.

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