Alembic
Pharmaceuticals Limited
(Alembic) announced that its
wholly-owned subsidiary, Aleor
Dermaceuticals Limited (Aleor)
has received final approval from
the US Food & Drug
Administration (USFDA) for its
Abbreviated New Drug
Application (ANDA) for
Docosanol Cream, 10 per cent (OTC).
The approved ANDA is therapeutically equivalent to the reference listed drug
product (RLD) Abreva Cream, 10 per cent (OTC) by GlaxoSmithKline Consumer
Healthcare. Docosanol Cream, 10 per cent (OTC), is used for cold sores or fever
blisters on the face or lips.
Alembic has received a cumulative total of 166 ANDA approvals (142 final
approvals and 24 tentative approvals) from the USFDA
