Lupin gets USFDA nod for generic equivalent of Invega ER Tablets
The product will be manufactured at Lupin’s facility in Goa, India.
Mumbai: Global pharma major, Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg, and 9 mg to treat Schizophrenia.
The product is a generic equivalent of Invega Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg, of Janssen Research and Development, LLC.
The product will be manufactured at Lupin's facility in Goa, India.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S. (IQVIA MAT March 2022).
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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.
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