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  • Unichem Laboratories gets USFDA nod to market muscle spasm tablets Jul 07, 2020 07:41 PM IST

    Unichem Laboratories gets USFDA nod to market muscle spasm tablets

    The company has received abbreviated new drug application (ANDA) approval to market its Cyclobenzaprine Hydrochloride tablets USP 5 mg, 7.5 mg and 10 mg from the United States Food and Drug Administration (USFDA), Unichem Labs said in a filing to the BSE.

  • US regulator greenlights Becton Dickinson's rapid antigen test for COVID-19 Jul 06, 2020 04:49 PM IST

    US regulator greenlights Becton Dickinson's rapid antigen test for COVID-19

    Antigen tests are a relatively new type of test for COVID-19 that work by scanning for proteins that can be found on or inside a virus.

  • Alembic Pharma gets USFDA nod for generic Doxycycline Hyclate tablets Jul 01, 2020 03:15 PM IST

    Alembic Pharma gets USFDA nod for generic Doxycycline Hyclate tablets

    The company's product is a generic version of Almirall, LLC's Acticlate tablets in the same strengths, Alembic Pharma said in a BSE filing.

  • USFDA to release guidance on COVID-19 vaccine approval Jun 30, 2020 06:30 PM IST

    USFDA to release guidance on COVID-19 vaccine approval

    The agency would require drugmakers to show "clearly demonstrated" proof of a vaccine's safety and effectiveness through a clinical study, and at least 50 percent more effectiveness than a placebo, the report said.

  • Zydus Cadila gets USFDA nod to market generic antihistamine tablets Jun 24, 2020 01:12 PM IST

    Zydus Cadila gets USFDA nod to market generic antihistamine tablets

    The company has received final approval from the United States Food and Drug Administration (USFDA) to market Meclizine hydrochloride tablets in the strengths of 12.5 mg and 25 mg, the company said in a statement.

  • USFDA has removed partial lifting of import alert on APIs manufacturing facility at Ratlam: Ipca Laboratories Jun 24, 2020 12:04 PM IST

    USFDA has removed partial lifting of import alert on APIs manufacturing facility at Ratlam: Ipca Laboratories

    In a regulatory filing Ipca Laboratories said, the US Food and Drug Administration (USFDA) has informed the company that the "shortage implications for chloroquine phosphate API has changed and chloroquine phosphate drug product is no longer in shortage and therefore, no shipment of API chloroquine phosphate will be excluded from the import alert."

  • Alembic Pharma gets tentative USFDA nod for generic Rivaroxaban tablets Jun 22, 2020 11:52 AM IST

    Alembic Pharma gets tentative USFDA nod for generic Rivaroxaban tablets

    The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) Rivaroxaban tablet is for multiple strengths of 10 mg, 15 mg, and 20 mg, Alembic Pharmaceuticals said in a regulatory filing.

  • Dr Reddy's Laboratories launches generic prostate cancer treatment drug in the US Jun 19, 2020 06:28 PM IST

    Dr Reddy's Laboratories launches generic prostate cancer treatment drug in the US

    The company has launched Abiraterone Acetate tablets USP in the strength of 250 mg, after the approval from the United States Food and Drug Administration (USFDA), Dr Reddy's Laboratories said in a filing to the BSE.

  • Alembic Pharmaceuticals gets USFDA nod for generic acne treatment gel Jun 19, 2020 02:16 PM IST

    Alembic Pharmaceuticals gets USFDA nod for generic acne treatment gel

    The approved product is a generic version of Galderma Laboratories LP's Differin gel in the same strength, it added.

  • Glenmark Pharmaceuticals gets USFDA nod for Fingolimod capsules Jun 19, 2020 09:57 AM IST

    Glenmark Pharmaceuticals gets USFDA nod for Fingolimod capsules

    "Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation," the drug major said in a filing to BSE.

  • EndeavorRX becomes the first video game ever to be prescribed as a form of medical treatment; gets USFDA nod Jun 17, 2020 03:20 PM IST

    EndeavorRX becomes the first video game ever to be prescribed as a form of medical treatment; gets USFDA nod

    The US Food and Drug Administration (FDA) has, for the first time, granted clearance for a video game to be used in treating children with attention deficit hyperactivity disorder (ADHD).

  • Alembic Pharma gets USFDA nod for generic chronic iron overload treatment tablets Jun 16, 2020 01:15 PM IST

    Alembic Pharma gets USFDA nod for generic chronic iron overload treatment tablets

    The company has received the final approval from the United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Deferasirox tablets in the strength of 180 mg, Alembic Pharmaceuticals said in a BSE filing.

  • Coronavirus pandemic | USFDA revokes emergency use status of hydroxychloroquine drug touted by Trump for COVID-19 Jun 15, 2020 09:55 PM IST

    Coronavirus pandemic | USFDA revokes emergency use status of hydroxychloroquine drug touted by Trump for COVID-19

    US FDA revoked the authorization following a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA).

  • Coronavirus drug | Dr Reddy's inks pact with Gilead Sciences to manufacture remdesivir Jun 13, 2020 04:20 PM IST

    Coronavirus drug | Dr Reddy's inks pact with Gilead Sciences to manufacture remdesivir

    As per the non-exclusive licensing agreement, Gilead will grant Dr Reddy's Laboratories the right to register and manufacture its investigational Coronavirus drug remdesivir in 127 countries.

  • Lupin gets USFDA nod to market generic anthelmintic tablets Jun 11, 2020 05:46 PM IST

    Lupin gets USFDA nod to market generic anthelmintic tablets

    The product is a generic version of Impax Laboratories Inc's Albenza tablets in the same strength, it added.

  • USFDA grants orphan drug status to mexiletine hydrochloride: Lupin Jun 08, 2020 12:24 PM IST

    USFDA grants orphan drug status to mexiletine hydrochloride: Lupin

    The Mumbai-based company's drug NaMuscula (mexiletine hydrochloride) is the first and only licensed product to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders.

  • Zydus Cadila gets USFDA nod for generic antiviral drug Jun 05, 2020 01:08 PM IST

    Zydus Cadila gets USFDA nod for generic antiviral drug

    The company has received final approval from the US Food and Drug Administration (USFDA) to market Atazanavir capsules in strengths of 150 mg, 200 mg and 300 mg, Zydus Cadila said in a statement.

  • FDA issues Form 483 with 9 observations to Aurobindo Pharma's USA facility Jun 04, 2020 04:47 PM IST

    FDA issues Form 483 with 9 observations to Aurobindo Pharma's USA facility

    The plant which makes oral solid manufacturing is situated at Dayton, New Jersey and was inspected by the FDA authorities from January 13, 2020 to February 12, 2020.

  • Lupin gets USFDA nod for generic osteoarthritis pain drug Jun 02, 2020 05:23 PM IST

    Lupin gets USFDA nod for generic osteoarthritis pain drug

    The company has received approval from the US Food and Drug Administration (USFDA) for meloxicam capsules in strength of 5 mg and 10 mg, Lupin Ltd said in a statement.

  • Strides Pharma gets USFDA nod for generic ointment to treat skin conditions Jun 02, 2020 12:20 PM IST

    Strides Pharma gets USFDA nod for generic ointment to treat skin conditions

    The approval is granted to the company's step-down wholly owned subsidiary, Strides Pharma Global, Singapore, by the United States Food and Drug Administration (USFDA) for triamcinolone acetonide ointment USP, 0.05 per cent, Strides Pharma Science said in a regulatory filing.

  • FDA approves emergency use of Abiomed heart pump for COVID-19 patients Jun 01, 2020 06:35 PM IST

    FDA approves emergency use of Abiomed heart pump for COVID-19 patients

    The agency said it believes the device will be effective at providing temporary right ventricular support, based on clinical experience.

  • Dr Reddy's gets inspection closure report from USFDA for Telangana facility May 28, 2020 03:45 PM IST

    Dr Reddy's gets inspection closure report from USFDA for Telangana facility

    The company has received the establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for Medchal-Malkajgiri-based integrated product development organisation (IPDO) indicating closure of the audit, Dr Reddy's Laboratories said in a regulatory filing.

  • Glenmark gets USFDA nod to market generic drug for muscle pain May 27, 2020 10:59 AM IST

    Glenmark gets USFDA nod to market generic drug for muscle pain

    Glenmark Pharmaceuticals Inc, USA has been granted final approval by the US Food and Drug Administration (USFDA) for Chlorzoxazone tablets USP, in strength of 375 mg and 750 mg, the drug maker said in a statement.

  • Cipla gets final nod from USFDA for migraine treatment nasal spray May 21, 2020 09:48 AM IST

    Cipla gets final nod from USFDA for migraine treatment nasal spray

    "It has received final approval for its Abbreviated New Drug Application (ANDA) for Dihydroergotamine Mesylate nasal spray 4mg/mL from the United States Food and Drug Administration (USFDA) with a competitive generic therapy (CGT) designation," the company said in a filing to BSE.

  • Cipla submits application with USFDA for generic version of asthma drug May 18, 2020 10:52 AM IST

    Cipla submits application with USFDA for generic version of asthma drug

    The company has submitted an abbreviated new drug application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the US Food and Drug Administration (USFDA), Cipla said in a regulatory filing.

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