you are here: HomeNewsUsfda
usfda
Jump to
1190 Results Found
  • Strides Pharma Science arm gets USFDA nod for pain relieving drug Feb 24, 2021 12:13 PM IST

    Strides Pharma Science arm gets USFDA nod for pain relieving drug

    The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Children's Motrin Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc.

  • Manufacturers may not require large randomised trials for updating COVID-19 vaccines against new variants: USFDA Feb 22, 2021 05:05 PM IST

    Manufacturers may not require large randomised trials for updating COVID-19 vaccines against new variants: USFDA

    'It will more likely be smaller immunogencity studies,' said Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at USFDA, speaking at BioAsia 2021 virtual event.

  • Aurobindo Pharma gets USFDA nod for generic Droxidopa capsules Feb 19, 2021 12:32 PM IST

    Aurobindo Pharma gets USFDA nod for generic Droxidopa capsules

    The approved product is a generic version of Lundbeck NA Ltd's Northera capsules.

  • Unichem Laboratories gets USFDA nod for plaque psoriasis treatment drug Feb 19, 2021 11:20 AM IST

    Unichem Laboratories gets USFDA nod for plaque psoriasis treatment drug

    Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

  • Strides Pharma Science receives USFDA approval for Prednisone tablets Feb 12, 2021 11:27 AM IST

    Strides Pharma Science receives USFDA approval for Prednisone tablets

    The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Deltasone tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co.

  • Alembic Pharma gets five observations from USFDA for Gujarat facility Feb 08, 2021 12:03 PM IST

    Alembic Pharma gets five observations from USFDA for Gujarat facility

    "The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals'' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021.

  • Glenmark Pharma gets USFDA nod for seizure treatment drug Feb 03, 2021 12:32 PM IST

    Glenmark Pharma gets USFDA nod for seizure treatment drug

    The approved product is a generic version of Qudexy XR Capsules of Upsher-Smith Laboratories, LLC.

  • Granules arm gets USFDA nod for Potassium Chloride Oral Solution Feb 01, 2021 11:09 AM IST

    Granules arm gets USFDA nod for Potassium Chloride Oral Solution

    The approved product is bioequivalent to the reference listed drug Potassium Chloride Oral Solution of Genus Lifesciences, Inc.

  • USFDA grants orphan drug designation to Zydus Cadila's Saroglitazar Mg Jan 28, 2021 11:25 AM IST

    USFDA grants orphan drug designation to Zydus Cadila's Saroglitazar Mg

    Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval.

  • Unichem Laboratories gets USFDA nod to market generic capsules Jan 27, 2021 04:45 PM IST

    Unichem Laboratories gets USFDA nod to market generic capsules

    The company has received abbreviated new drug application (ANDA) approval to market its Zonisamide capsules, USP 25 mg, 50 mg and 100 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a BSE filing.

  • Strides Pharma Science gets USFDA nod for generic drug Jan 25, 2021 01:58 PM IST

    Strides Pharma Science gets USFDA nod for generic drug

    The company's product is bioequivalent and therapeutically equivalent to Allergan Sales' Actigall capsules, Strides Pharma Science added.

  • Lupin gets USFDA nod to market generic Sevelamer Carbonate tablets Jan 25, 2021 01:54 PM IST

    Lupin gets USFDA nod to market generic Sevelamer Carbonate tablets

    The product is a generic version of Genzyme Corporation's Renvela tablets in the same strength, Lupin added.

  • Alembic Pharma gets USFDA nod for low blood pressure treatment drug Jan 22, 2021 11:47 AM IST

    Alembic Pharma gets USFDA nod for low blood pressure treatment drug

    The approved product is therapeutically equivalent to the reference listed drug product ProAmatine tablets of Takeda Pharmaceuticals USA, Inc.

  • Unichem Laboratories gets USFDA nod to market generic Celecoxib capsules Jan 13, 2021 01:41 PM IST

    Unichem Laboratories gets USFDA nod to market generic Celecoxib capsules

    The company has received abbreviated new drug application (ANDA) approval for its Celecoxib capsules in the strengths of 50 mg, 100 mg, 200 mg, and 400 mg from the United States Food and Drug Administration (USFDA), Unichem said in a filing to BSE.

  • Lupin gets USFDA nod for generic diabetes drug Jan 07, 2021 05:26 PM IST

    Lupin gets USFDA nod for generic diabetes drug

    The product will be manufactured at Lupin’s Nagpur-based manufacturing facility.

  • Glenmark Pharma gets tentative nod from USFDA for anticoagulant drug Dec 21, 2020 11:11 AM IST

    Glenmark Pharma gets tentative nod from USFDA for anticoagulant drug

    The approved product is a generic version of Boehringer Ingelheim Pharmaceuticals’ Pradaxa capsules. Pradaxa is used to prevent blood clots from forming because of certain irregular heart rhythm.

  • Moderna vaccine shows 'no specific safety concerns', has 94.1% efficacy: US regulator Dec 15, 2020 07:02 PM IST

    Moderna vaccine shows 'no specific safety concerns', has 94.1% efficacy: US regulator

    The FDA was upbeat on the vaccine, saying there were "no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization" and confirmed an overall efficacy of 94.1 percent.

  • Zydus Cadila gets USFDA Fast Track Designation for Saroglitazar Dec 09, 2020 03:32 PM IST

    Zydus Cadila gets USFDA Fast Track Designation for Saroglitazar

    Fast Track is a process of the USFDA to expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track Designation is eligible for accelerated approval and priority review, if the relevant criteria are met, Zydus Cadila said in a statement.

  • Glenmark Pharma gets tentative nod from USFDA for cancer treatment drug Dec 01, 2020 11:41 AM IST

    Glenmark Pharma gets tentative nod from USFDA for cancer treatment drug

    The tentatively approved product is the generic version of Inlyta tablets of PF Prism CV.

  • 3-Point Analysis | Why AstraZeneca's COVID vaccine may be more suitable for India than Pfizer, Moderna shots Nov 24, 2020 02:40 PM IST

    3-Point Analysis | Why AstraZeneca's COVID vaccine may be more suitable for India than Pfizer, Moderna shots

    Watch the video to find out how a dosing error turned into a lucky punch for AstraZeneca and Oxford.

  • Pfizer is first to apply for US emergency use for COVID-19 vaccine Nov 20, 2020 06:06 PM IST

    Pfizer is first to apply for US emergency use for COVID-19 vaccine

    The application to the US Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.

  • Alembic Pharmaceuticals gets tentative USFDA nod for breast cancer treatment drug Nov 09, 2020 11:34 AM IST

    Alembic Pharmaceuticals gets tentative USFDA nod for breast cancer treatment drug

    The approved product is therapeutically equivalent to the reference listed drug product lbrance Capsules of Pfizer Inc.

  • USFDA issues 13 observations after inspection of Lupin arm's Somerset facility Nov 09, 2020 11:13 AM IST

    USFDA issues 13 observations after inspection of Lupin arm's Somerset facility

    Lupin said it does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility.

  • Alembic Pharmaceuticals gets USFDA nod for elevated intraocular pressure drug Oct 26, 2020 02:21 PM IST

    Alembic Pharmaceuticals gets USFDA nod for elevated intraocular pressure drug

    The product is generic version of Bausch Health US’ Timoptic-XE ophthalmic gel forming solution in the same strengths, the company added.

  • Zydus Cadila gets USFDA nod for generic drug Oct 23, 2020 12:47 PM IST

    Zydus Cadila gets USFDA nod for generic drug

    The company has received final approval from the US Food and Drug Administration (USFDA)to market its product, which is a generic version of Proventil tablets, Zydus Cadila said in a statement.

Sections