Alembic Pharma receives USFDA approval for Desonide lotion

The drug maker said it received US drug regulator's approval for Desonide lotion used to treat a variety of skin conditions.

Alembic Pharmaceutical said that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Desonide lotion.

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

According to IQVIA, Desonide Lotion has an estimated market size of $7 million for twelve months ending June 2020. Alembic has a cumulative total of 129 ANDA approvals (113 final approvals and 16 tentative approvals) from USFDA.

Shares of Alembic Pharmaceutical were trading 0.2% higher at Rs 1010.1 on BSE. The scrip traded in the range of Rs 995.70 to Rs 1016.80 so far during the day.

Aleor Dermaceuticals is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologiesformed in Apr 2016 focusing on commercialising dermatology products globally.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

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