You are here: Home » News-CM » Companies » News
Business Standard

Alembic Pharmaceuticals receives USFDA approval for Teriflunomide Tablets

Topics
Health Medical Pharma

Capital Market 

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Teriflunomide Tablets, 7 mg and 14 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Aubagio Tablets, 7 mg and 14 mg, of Sanofi-Aventis U.

S., LLC (Sanofi-Aventis). Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Teriflunomide Tablets, 7 mg and 14 mg have an estimated market size of US$ 1.6 billion for twelve months ending December 2018 according to IQVIA. Alembic has settled the litigation and will launch the product as per the terms of the settlement.

Alembic now has a total of 91 ANDA approvals (79 final approvals and 12 tentative approvals) from USFDA.

Powered by Capital Market - Live News

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)


Subscribe to Business Standard Premium

Exclusive Stories, Curated Newsletters, 26 years of Archives, E-paper, and more!

Insightful news, sharp views, newsletters, e-paper, and more! Unlock incisive commentary only on Business Standard.

Download the Business Standard App for latest Business News and Market News .

First Published: Mon, April 22 2019. 11:25 IST
RECOMMENDED FOR YOU
RECOMMENDED FOR YOU