Lupin gets US FDA approval for Paliperidone Extended-Release Tablets

Pharma major Lupin on Thursday announced that it has received approval from the United States Food and Drug Administration (FDA) to market Paliperidone Extended-Release Tablets in the American market.

Paliperidone extended-release tablets are used to treat Schizophrenia.

The drug maker in a regulatory filing said, "It has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg, and 9 mg, to market 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).

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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.