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  • Indoco Remedies' CRO clears USFDA inspection with no observation Sep 19, 2022 01:15 PM IST

    Indoco Remedies' CRO clears USFDA inspection with no observation

    The US Food and Drug Administration (USFDA) inspected AnaCipher from September 12-16, 2022, Indoco Remedies said in a regulatory filing.

  • Zydus gets USFDA nod for anti-cancer drug Sep 13, 2022 01:30 PM IST

    Zydus gets USFDA nod for anti-cancer drug

    Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells

  • USFDA asks Panacea Biotec to take corrective measures at Himachal unit Sep 08, 2022 04:01 PM IST

    USFDA asks Panacea Biotec to take corrective measures at Himachal unit

    The USFDA has issued Form 483 with eight observations that are related to improvements in existing procedures and are addressable, Panacea Biotec said in a regulatory filing.

  • Cipla gets USFDA nod for cancer drug Sep 07, 2022 02:39 PM IST

    Cipla gets USFDA nod for cancer drug

    The company has received the final approval from the US Food and Drug Administration (USFDA) for the product in strengths of 5 mg, 10 mg, 15 mg and 25 mg, Cipla said in a regulatory filing.

  • Alembic Pharma gets USFDA nod for blood pressure drug Aug 29, 2022 02:28 PM IST

    Alembic Pharma gets USFDA nod for blood pressure drug

    The company has received final approval from the US Food and Drug Administration (USFDA) to market the product in the US in strengths of 25 mg and 50 mg, the drug maker said in a statement.

  • Unichem gets USFDA nod for generic medication Aug 23, 2022 03:30 PM IST

    Unichem gets USFDA nod for generic medication

    On Tuesday, the pharmaceutical company Unichem Laboratories said the US Food and Drug Administration (USFDA) has given the firm the go-ahead to market its medication with a 200 mg dosage.

  • Lupin gets USFDA nod for generic drug to treat seizures Aug 18, 2022 03:02 PM IST

    Lupin gets USFDA nod for generic drug to treat seizures

    The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of rufinamide tablets of strengths 100 mg, 200 mg, and 400 mg

  • Aurobindo Pharma arm gets final USFDA nod for Vasopressin injection Aug 16, 2022 11:26 AM IST

    Aurobindo Pharma arm gets final USFDA nod for Vasopressin injection

    The injection is indicated to increase blood pressure in adults who suffer from sudden relaxation of blood vessels.

  • Lupin gets USFDA nod for generic drug Aug 12, 2022 09:36 PM IST

    Lupin gets USFDA nod for generic drug

    The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of meclizine hydrochloride tablets of strengths 12.5 mg, 25 mg, and 50 mg, the pharmaceuticals company said in a regulatory filing.

  • Alembic Pharma arm gets USFDA nod for generic topical gel for acne vulgaris Aug 08, 2022 01:36 PM IST

    Alembic Pharma arm gets USFDA nod for generic topical gel for acne vulgaris

    The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for adapalene and benzoyl peroxide topical gel of strength 0.3 per cent/2.5 per cent, Alembic said in a statement.

  • Zydus Lifesciences gets final USFDA approval to market anti-inflammatory skin cream Aug 04, 2022 02:24 PM IST

    Zydus Lifesciences gets final USFDA approval to market anti-inflammatory skin cream

    The approval granted by the US Food and Drug Administration (USFDA) is for Ivermectin cream, 1 per cent, the generic equivalent of reference listed drug Soolantra, Zydus Lifesciences said in a regulatory filing.

  • Alembic Pharma receive USFDA approval to market drug for skin treatment Jul 29, 2022 02:08 PM IST

    Alembic Pharma receive USFDA approval to market drug for skin treatment

    Aleor Dermaceuticals has received approval from the US Food and Drug Administration (USFDA) for Diclofenac Sodium topical gel, the drug firm said in a statement.

  • Glenmark Pharma arm gets final USFDA nod for birth control capsules Jul 29, 2022 10:53 AM IST

    Glenmark Pharma arm gets final USFDA nod for birth control capsules

    The approval granted by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc is for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules of strength 1 mg/20 mcg, the company said in a statement.

  • Dr Reddy's launches cancer treatment injection Bortezomib in US Jul 27, 2022 11:17 AM IST

    Dr Reddy's launches cancer treatment injection Bortezomib in US

    The Hyderabad-based drug major has launched the product after getting approval from the US Food and Drug Administration (USFDA).

  • Zydus Lifesciences gets USFDA nod to market generic high blood pressure drug Jul 26, 2022 05:01 PM IST

    Zydus Lifesciences gets USFDA nod to market generic high blood pressure drug

    The approval granted by the US Food and Drug Administration (USFDA) is for bisoprolol fumarate tablets of strengths 5 mg and 10 mg, Zydus Lifesciences Ltd said in a regulatory filing.

  • Lupin gets USFDA nod for generic blood pressure lowering drug Jul 25, 2022 08:29 PM IST

    Lupin gets USFDA nod for generic blood pressure lowering drug

  • Natco Pharma's partner Breckenridge Pharmaceutical gets USFDA nod for cancer treatment drug Jul 25, 2022 10:51 AM IST

    Natco Pharma's partner Breckenridge Pharmaceutical gets USFDA nod for cancer treatment drug

    The approval granted by the US Food and Drug Administration to Breckenridge Pharmaceutical Inc' is for the abbreviated new drug application for Cabazitaxel intravenous powder of strength 60mg/1.5ml (40mg/ml), the company said in a regulatory filing.

  • Sun Pharma, Glenmark recall products in US due to manufacturing issues Jul 24, 2022 03:01 PM IST

    Sun Pharma, Glenmark recall products in US due to manufacturing issues

    According to the US health regulator, the Mumbai-based drug major is recalling the affected lot due to ''water leakage'' leading to deviation from current good manufacturing practices (cGMP).

  • Lupin's Somerset manufacturing plant receives EIR from US FDA Jul 07, 2022 11:32 AM IST

    Lupin's Somerset manufacturing plant receives EIR from US FDA

    The US Food and Drug Administration (US FDA) had inspected the facility in March 2022, the company said in a regulatory filing.

  • Zydus gets USFDA's final approval for Lacosamide injection Jun 30, 2022 05:43 PM IST

    Zydus gets USFDA's final approval for Lacosamide injection

    Lacosamide injection is used to treat partial-onset seizures.

  • Aurobindo Pharma receives 'warning letter' from SEBI over USFDA audit row Jun 27, 2022 02:42 PM IST

    Aurobindo Pharma receives 'warning letter' from SEBI over USFDA audit row

    Aurobindo Pharma "disclosed very limited and restricted information" about the warning it had received from the American drug regulator, SEBI said.

  • Strides Pharma recalls over 6 lakh bottles of blood pressure treatment tablets in US Jun 12, 2022 04:51 PM IST

    Strides Pharma recalls over 6 lakh bottles of blood pressure treatment tablets in US

    As per the latest enforcement report by the US Food and Drug Administration (USFDA), the company, which is a unit of Bengaluru-headquartered Strides Pharma Science, is recalling 6,78,829 bottles of the blood pressure lowering drug in the US market.

  • Alembic gets USFDA nod for cancer treatment drug Jun 10, 2022 12:24 PM IST

    Alembic gets USFDA nod for cancer treatment drug

    The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Alembic Pharmaceuticals said in a statement.

  • Lupin gets USFDA nod for generic drug Jun 08, 2022 02:30 PM IST

    Lupin gets USFDA nod for generic drug

    The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ivacaftor tablets, 150 mg strength, Lupin said in a statement.

  • Zydus gets USFDA nod for generic antacid Jun 06, 2022 01:01 PM IST

    Zydus gets USFDA nod for generic antacid

    The company has received approval from the US Food and Drug Administration to market the drug in the strengths of 20mg and 40mg, the company said in a statement.

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