Lupin receives approval from U.S. FDA for Iloperidone Tablets

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Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Iloperidone Tablets, 1 mg, 2. mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to market a generic equivalent of Fanapt® Tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg of Vanda Pharmaceuticals Inc. The product will be manufactured at Lupin’s facility in Goa, India.

Iloperidone Tablets (RLD Fanapt®) had estimated annual sales of USO 162 million in the U.S. (IQVIA MAT March 2022).