Lupin gets USFDA nod for generic drug
- Country:
- India
Drug maker Lupin on Thursday said it has received approval from the US health regulator to market Paliperidone extended-release tablets, used to treat Schizophrenia, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Paliperidone extended-release tablets in strength of 1.5 mg, 3 mg, 6 mg, and 9 mg, the Mumbai-based drug maker said in a statement.
The company's product is a generic version of Janssen Research and Development's Invega extended-release tablets.
Lupin said the drug will be manufactured at its Goa-based plant.
As per IQVIA MAT March 2022 data, Paliperidone extended-release tablets had an estimated annual sales of USD 152 million in the US.
Google News