• Zydus gets USFDA node for insomnia drug
    2 January 2023

    Zydus gets USFDA node for insomnia drug

    Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Triazolam Tablets USP, 0.125 mg and 0.25 mg.

    Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep). It works by slowing activity in the brain to allow sleep. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.

  • 26 December 2022
    Alembic Pharma receives USFDA final approval for Fulvestrant Injection

    Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single- Dose Prefilled Syringe.

  • 9 December 2022
    Alembic Pharma receives EIR for Panelav facility

    Alembic Pharmaceuticals Limited receives Establishment Inspection Report (EIR) for its Oncology Injectable Formulation Facility at Panelav.

    US Food and Drug Administration (USFDA) for the inspection carried out by them at Alembic's Oncology Injectable Formulation Facility at Panelav during the period from 4th October, 2022 to 14th October, 2022.

  • 2 December 2022
    FDA lays aside Lillys Bebtelovimab in the U.S.

    FDA lays aside Lilly's bebtelovimab in the U.S. for emergency use treatment of mild-to-moderate COVID-19 in adults and pediatric patients. Over the last several months, prevalence of COVID variant sublineages vary by state, region and even country, and can change rapidly.

    Lilly said that it agrees with the FDA that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate COVID-19 with bebtelovimab in the US.

  • 1 December 2022
    Alembic Pharma receives USFDA Approval for Diclofenac Sodium Topical Solution

    Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

  • 19 November 2022
    FDA approves First Drug that can Delay Onset of Type 1 Diabetes

    The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

  • 18 November 2022
    SEZABY approved by USFDA for the treatment of neonatal seizures

    Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (US FDA) has approved SEZABY  (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. With this approval, SEZABY becomes the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the U.S. in Q4FY23.

  • 4 November 2022
    Lupin receives FDA nod for contraceptive

    Lupin Limited has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market a generic equivalent of Slynd Tablets, 4 mg, of Exeltis USA Inc.

    Drospirenone is a progestin medication which is used as contraceptive to prevent pregnancy and in menopausal hormone therapy, among other uses.

  • 3 November 2022
    Alembic receives approval from the USFDA for Ketorolac Tromethamine

    Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials.

    This is the second injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.

  • 21 October 2022
    USFDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine

    Novavax, Inc a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S.

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