Medicaloid
Pharmaceutical

Aleor Dermaceuticals gets tentative USFDA nod for Efinaconazole topical solution

New Delhi: Drug firm Alembic Pharmaceuticals on Thursday said its joint venture firm Aleor Dermaceuticals has received tentative approval from the US health regulator for Efinaconazole topical solution, used for treatment of fungal toenail infections. The tentatively approved product is therapeutically equivalent to the reference listed drug product Jublia topical solution, 10 per cent, of Bausch Health Americas.

Aleor Dermaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Efinaconazole topical solution, 10 per cent, Alembic Pharma said in a regulatory filing.

The solution is indicated for the topical treatment of onychomycosis of the toenails.

Quoting IQVIA data, Alembic Pharma said Efinaconazole topical solution, 10 per cent, has an estimated market size of USD 233 million for 12 months ending December 2020.

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

Follow and connect with us on , Facebook, Linkedin

Source link

Related posts

Eight organizations and 145 individuals write to govt on concerns on Aarogya Setu app

Medicaloid

50% super-specialty, PG medical seats for government doctors in Tamil Nadu

Medicaloid

SPARC licenses commercialisation rights of anti-epileptic drug to Tripoint Therapeutics

Medicaloid