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Lupin receives USFDA approval for Paliperidone Extended-Release Tablets
(01 Jul 2022, 15:48)
Lupin announced that 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).

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