USFDA gives nod to Lupin for Vigabatrin for Oral Solution

The product is the generic equivalent of Lundbeck Pharmaceuticals’ Sabril for Oral Solution.

182
USFDA Approval
USFDA Approval

Last Updated on October 15, 2024 by The Health Master

Lupin recently said it has received approval from the US health regulator to market its anti-epilepsy drug Vigabatrin for Oral Solution in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Vigabatrin for Oral Solution USP (500 mg), Lupin said in a statement.

The product is the generic equivalent of Lundbeck Pharmaceuticals’ Sabril for Oral Solution.

The product will be manufactured at Lupin’s manufacturing facility in Goa, it added.

As per IQVIA MAT December 2021 data, Vigabatrin for Oral Solution USP (500 mg) had an estimated annual sales of $275 million (around Rs 2,100 crores) in the US.

USFDA gives tentative nod to Alembic for Macitentan Tablets 10 mg

USFDA gives final nod to Zydus for Colestipol Hydrochloride tablets

USFDA gives nod to Strides Pharma for Colchicine tablets

USFDA gives nod to Alembic Pharmaceuticals for anti fungal drug

USFDA gives nod to Aleor for Nystatin and Triamcinolone Acetonide Ointment

USFDA approves expanded use of cancer drug Opdivo

Availability of drugs at reasonable price: NPPA

Medical Device testing on patients not soon

Demand for framing of statutory working rules in Pharma industry

Drug recall: Fresenius Kabi recalled Sodium Acetate Injection, USP Due to…

USFDA complete audit of Granules Pharmaceuticals with 3 observations

USFDA gives tentative nod to Alembic for Macitentan Tablets 10 mg

Govt releases draft National Medical Device Policy 2022

Deadline extended for proposals under PLI scheme for Bulk Drugs

USFDA gives final nod to Zydus for Colestipol Hydrochloride tablets

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news