Last Updated on December 31, 2023 by The Health Master
Alembic Pharmaceuticals today received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dronedarone tablets, USP, 400 mg.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug (RLD) product Multaq tablets, 400 mg, by Sanofi-Aventis US LLC (Sanofi-Aventis), the company said in a statement.
Dronedarone is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation, it added.
Dronedarone tablets USP, 400 mg have an estimated market size of $500 million for twelve months ending September 2021 according to IQVIA.
Alembic has settled the case with Sanofi-Aventis and will launch its generic as per the terms of settlement, concluded the statement.
USFDA gives nod to Alembic Pharma for Vortioxetine tablets
USFDA gives nod to Alembic for generic drug to treat Parkinson’s disease
USFDA gives nod to Alembic Pharma for Doxycycline Hyclate tablets
USFDA gives tentative nod to Zydus Cadila for Pimavanserin capsules
USFDA gives tentative nod to Amphastar Pharma for Vasopressin injection
USFDA gives nod to Granules India for Prazosin HCL capsules
DCGI raises alarm over suspected spurious Tocilizumab injections in India
Drug recall: Clobetasol Propionate Ointment recalled due to this reason
3rd booster shot of Covaxin shows positive responses
FDA asks Chemists and Hospitals to ramp up medicine supply
India to become hub for Covid-19 antiviral medicines
15 New Drugs to be developed: Sanofi
DTAB agrees to amend Rules for OTC drugs and license displaying…
IPC releases 9th amendment list of 40 monographs to IP 2018
USFDA gives nod to Alembic Pharma for Vortioxetine tablets
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
