USFDA nod to Lupin Iloperidone tablets
Mumbai: Lupin Limited has recently announced that the company 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.
The product is 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.
FANAPT is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.
The medicine 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).
Read also: Lupin gets USFDA nod for generic equivalent of Lyrica Capsules
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.
Read also: Lupin Diagnostics unveils reference lab in Guwahati
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