Last Updated on October 10, 2024 by The Health Master
Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Desipramine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Norpramin Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, of Validus Pharmaceuticals. Desipramine Hydrochloride Tablets, USP are indicated for the treatment of depression.
Desipramine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg have an estimated market size of $7 million for twelve months ending March 2021 according to IQVIA.
Alembic has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA.
USFDA approves Abbott’s Stent to treat high bleeding risk patients
Zydus Cadila gets USFDA nod for drug to treat HIV infection
Alembic gets USFDA nod for Nitrofurantoin Capsules USP
Axio Biosolution gets USFDA nod for Patch for bleeding control
Glenmark gets USFDA nod for generic Lung cancer drug
USFDA okays Tocilizumab for treatment of Covid-19
Latest Notifications: General (Pharmaceuticals)
Latest Circulars: (IPC) Indian Pharmacopoeia Commission
Starch powder sold as Black Fungus medicine: Scam busted
NPPA fixes price of drug for the treatment of Black Fungus
CDSCO asks Philips India to discontinue these Ventilators
NABL 126: Specific criteria for calibration of Medical Devices
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:
