Alembic Pharmaceuticals announces USFDA approval for Desonide Lotion

Alembic Pharmaceuticals informed the bourses on Tuesday that its joint venture, Aleor Dermaceuticals Limited, has received final approval from United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Desonide
Lotion, 0.05 per cent.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), DesOwen Lotion, 0.05 per cent of Galderma Laboratories LP. Desonide Lotion is low to medium potency corticosteroids indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

As per IQVIA, the market size for this approved product is around US$ 7 million as on twelve-month ending June 2020.

Alembic Pharmaceuticals Limited, vertically integrated research, and development pharmaceutical company, has a cumulative total of 129 ANDA approvals (113 final approvals and 16 tentative approvals) from USFDA.

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd formed in April 2016, which focusses on commercialising dermatology products globally.

The stock of Alembic Pharmaceuticals in today's session was trading in negative terrain. The stock, which opened higher at Rs 1,016.80, later cooled down and dipped nearly 1.2 per cent to touch an intraday low of Rs 995.7.