The Abbreviated New Drug Application (ANDA) was filed by Aleor Dermaceuticals Ltd., which was amalgamated with Alembic Pharma.
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Alembic Pharmaceuticals Ltd. on Thursday said that it has received final approval from the United States Food and Drug Administration (USFDA) for Diclofenac Sodium Topical Solution USP 2 percent w/w.
Diclofenac Sodium Topical Solution is used for the treatment of arthritis pain in knees, ankles, feet, elbows, wrists, and hands.
The Abbreviated New Drug Application (ANDA) was filed by Aleor Dermaceuticals Ltd., which was amalgamated with Alembic Pharma. Alembic Pharma completed the acquisition of Aleor Dermaceuticals in March of this year.
Diclofenac Sodium Topical Solution is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2 percent w/w, of Horizon Therapeutics Ireland DAC (Horizon).
According to IQVIA, Diclofenac Sodium Topical Solution USP 2 percent w/w has an estimated market size of $ 512 million in the United States for the 12-month period that ended in September.
In November, Alembic received approval from the USFDA for Nifedipine extended-release tablets, Cyclophosphamide Capsules, Ketorolac Tromethamine Injection USP, Glycopyrrolate Injection USP, and Mesalamine Extended capsules.
Overall, Alembic has received a cumulative total of 177 ANDA clearances comprising 154 final approvals and 23 tentative approvals from the USFDA.
Shares of Alembic are trading 0.18 percent higher at Rs 596.05.
(Edited by : Rukmani Krishna)