Alembic gets USFDA nod for drug to treat IPF

AHMEDABAD: Vadodara-based

Alembic Pharmaceuticals Limited

on Tuesday announced in it regulatory filing that it has received final approval from the

US Food and Drug Administration

(

USFDA

) for its abbreviated new drug application (ANDA) for Pirfenidone Tablets in 267 mg and 801 mg doses.


Pirfenidone tablets are prescribed for treatment of idiopathic pulmonary fibrosis (IPF).

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Esbriet Tablets, 267 mg and 801 mg, of

Genentech Inc.

Alembic had previously received tentative approval for this ANDA. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

Alembic has settled the case with

Genetech

and will launch its generic as per the terms of settlement.

Alembic has a cumulative total of 144 final approvals and 23 tentative approvals from USFDA.