Drug firm Alembic Pharmaceuticals on Tuesday said its joint venture firm Aleor Dermaceuticals has received final approval from the US health regulator for Desonide lotion, used to treat a variety of skin conditions. The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product DesOwen Lotion, 0.05 per cent, of Galderma Laboratories LP.
“Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its ANDA for Desonide lotion, 0.05 per cent,” Alembic Pharmaceuticals informed stock exchanges.
Desonide lotion is low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Quoting IQVIA data, Alembic Pharma said Desonide lotion, 0.05 per cent, has an estimated market size of USD 7 million for 12 months ending June 2020.
Alembic Pharma has a cumulative total of 129 ANDA approvals (113 final approvals and 16 tentative approvals) from USFDA.
Shares of Alembic Pharmaceuticals were trading 0.67 per cent lower at Rs 1,001.30 apiece on the BSE.