Aleor gets tentative USFDA nod for drug for topical treatment

Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail

140
USFDA Approval
USFDA Approval

Last Updated on October 15, 2024 by The Health Master

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%. T

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch).

Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Efinaconazole Topical Solution, 10% has an estimated market size of $233 million for twelve months ending December 2020 according to IQVIA.

Aleor has settled the case with Bausch Health and will launch its generic as per the terms of settlement.

Alembic has a cumulative total of 140 ANDA approvals (123 final approvals and 17 tentative approvals) from USFDA.


Also read:

Zydus Cadila gets final USFDA nod for drug to treat High…

Dr Reddy’s launch generic Sapropterin Dihydrochloride Powder for Oral Solution in…

Camber Pharma Launches Generic Succinylcholine Chloride Inj

Aleor gets USFDA nod for drug for cutaneous candidiasis treatment

Zealand Pharma got USFDA nod for severe Hypoglycemia drug

Glenmark gets USFDA nod for Chlorpromazine HCL tablets

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