Last Updated on October 15, 2024 by The Health Master
Indoco Remedies Ltd. announced that the United States Food & Drug Administration (USFDA) has approved the ANDA lacosamide injection USP, 200 mg/20 mL (10 mg/mL) single-dose vials.
The generic lacosamide injection USP of Indoco Remedies is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vimpat injection of UCB, Inc.
Lacosamide injection is indicated for the prevention and control of seizures. It is an anticonvulsant / antiepileptic drug.
Commenting on the development, Aditi Kare Panandikar, managing director-Indoco Remedies said, “Lacosamide injection of Indoco is the first generic version of Vimpat injection of UCB Inc., approved in the United States.
The ANDA approval and immediate launch of the product in the US market, echoes our commitment and consistent efforts to meet the unmet needs of the patients with quality and affordable healthcare.”
According to available IQVIA, sales data for Vimpat injection is approx. USD 43.8 million, growing at 25%.
USFDA gives tentative approval to Alembic for generic Pradaxa capsules
USFDA approves Cell Therapy for earlier lymphoma
USFDA approves Ozempic 2 mg to treat Type-II Diabetes
USFDA gives nod to Lupin for Sildenafil for oral suspension
USFDA gives approval to Glenmark Pharma for Lacosamide Tablets
USFDA approves drug for treatment of Seizures associated with rare disease
USFDA gives tentative approval to Alembic for generic Pradaxa capsules
Track and trace system implementation for export of drugs extended
USFDA issues 4 Observations to Lupin for Tarapur Facility
Dr Reddy’s launches generic Methylprednisolone Sodium Succinate for injection
Certain Products recalled due to Microbial Contamination
USFDA approves Cell Therapy for earlier lymphoma
Drug Recall: IDArubicin Hydrochloride Injection recalled due to this reason
USFDA gives 13 observations to Lupin
Govt further extends timeline to apply for slots under PLI scheme
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
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:
