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    Zydus Lifesciences Gains USFDA Approval for Generic Dapagliflozin

    New Delhi, April 8 Zydus Lifesciences Ltd announced on Wednesday that it has received final approval from the US health regulator for its generic version of dapagliflozin tablets, indicated for controlling blood sugar in adults with type 2 diabetes mellitus.The approval from the US Food and...
    • Ananya
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    • ahmedabad blood sugar control dapagliflozin diabetes mellitus generic drugs pharmaceuticals tablet formulation type 2 diabetes united states usfda zydus lifesciences
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    Aurobindo Pharma Secures USFDA Approval for Generic Dapagliflozin

    New Delhi, April 7 Aurobindo Pharma announced on Tuesday that it has received final approval from the US health regulator for its generic version of dapagliflozin tablets, which are used to control blood sugar levels in people with type 2 diabetes.The final approval granted by the US Food &...
    • Kavya
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    • anda apl healthcare ltd aurobindo pharma bioequivalence dapagliflozin diabetes management generic pharmaceuticals market size metformin pharmaceutical approval shared generic drug marketing exclusivity therapeutic equivalence type 2 diabetes us food & drug administration usfda
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    • Forum: Business
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    Alembic Pharmaceuticals Secures USFDA Approval for Generic Dapagliflozin

    New Delhi, April 7 Alembic Pharmaceuticals Ltd announced on Tuesday that it has received final approval from the US health regulator for its generic version of dapagliflozin tablets, used to control blood sugar levels in people with type-2 diabetes.The approval from the US Food & Drug...
    • Abhishek
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    • alembic pharmaceuticals anda blood sugar cardiovascular disease dapagliflozin diabetes generic drug heart failure metformin pharmaceuticals regulatory approval tablet therapeutic equivalence type 2 diabetes usfda
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    • Forum: Business
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    USFDA Approves Lupin's Generic Sugammadex for Muscle Relaxant Reversal

    New Delhi, March 31 Pharma major Lupin Ltd announced on Tuesday that it has received tentative approval from the US health regulator for its generic version of Sugammadex injection, used for reversing the effects of muscle relaxants administered during surgery.The tentative approval by the US...
    • Kangana
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    • adults bioequivalence generic drug injection lupin medical devices muscle relaxants neuromuscular blockade pediatrics pharmaceutical approval pharmaceuticals rocuronium bromide sugammadex surgery usfda vecuronium bromide
    • Replies: 0
    • Forum: Business
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    Alembic Pharmaceuticals Receives USFDA Approval for Paroxetine Tablet

    New Delhi, March 30 Alembic Pharmaceuticals Ltd announced on Monday that it has received final approval from the US health regulator for its generic version of Paroxetine extended-release tablets, indicated for various mental health conditions.The approval from the US Food & Drug...
    • Shishta
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    • alembic pharmaceuticals extended-release tablets generic drugs major depressive disorder mental health panic disorder paroxetine premenstrual dysphoric disorder social anxiety disorder supplemental abbreviated new drug application (sanda) usfda
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    • Forum: Business
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    Andhra Plant Receives Satisfactory Inspection Report from USFDA

    New Delhi, March 12 Aurobindo Pharma announced on Thursday that it has received an inspection report from the US health regulator, classifying its wholly-owned subsidiary's manufacturing unit in Andhra Pradesh as having a "Voluntary Action Indicated" (VAI) classification, which indicates...
    • Shivani
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    • andhra pradesh apl healthcare aurobindo pharma bse establishment inspection report form 483 healthcare sector india manufacturing nellore district pharmaceutical industry pharmaceutical inspection regulatory filings usfda voluntary action indicated
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    • Forum: Business
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    Lupin Launches Generic Seizure Treatment in the US

    New Delhi, February 25 Drug firm Lupin announced on Wednesday that it has received approval from the US health regulator to market a generic medication to treat seizures.The Mumbai-based firm has received approval from the USFDA for its abbreviated new drug application (ANDA) for Brivaracetam...
    • Priya
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    • anda brivaracetam briviact bse drug approval generic medication india lupin oral solution pharmaceutical industry pharmaceutical sales seizures us market usfda
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    • Forum: Business
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