Lupin gets nod from USFDA for Iloperidone tablets

06 May 2022 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) 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.

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

Lupin Diagnostics is a part of Lupin Healthcare, which is a 100% subsidiary of Lupin. Meanwhile, Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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