Alembic Pharma arm bags USFDA nod for Diclofenac Sodium Topical Gel
Diclofenac Sodium Topical Gel, 3% is indicated for the topical treatment of actinic keratoses.
Vadodara: Alembic Pharmaceuticals Limited today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 3%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze Topical Gel, 3%, of Fougera Pharmaceuticals Inc.
Diclofenac Sodium Topical Gel, 3% is indicated for the topical treatment of actinic keratoses. Sun avoidance is indicated during therapy.
Actinic keratosis, sometimes known as solar keratosis is a pre-cancerous area of thick, crusty, or scaly skin.
Diclofenac Sodium Topical Gel, 3% has an estimated market size of. US$10 million for twelve months ending Mar., 2022 according to IQVIA. Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.
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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
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