Lupin Wins FDA Nod for Risperidone

  Published 10 months ago

Lupin gained USFDA approval for Risperidone LAI, leveraging Nanomi technology, securing 180-day CGT exclusivity.

  • Risperidone LAI treats schizophrenia, bipolar I disorder and is bioequivalent to Risperdal Consta long-acting injection.
  • Lupin’s first Nanomi-based product approval validates its LAI platform, strengthening its specialty injectables pipeline and innovation strategy.
  • IQVIA reported annual US sales for Risperidone extended-release injectable suspension estimated at $190 million.

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