(RTTNews) - Lupin (LUPIN) has received approval from the FDA for its Abbreviated New Drug Application for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials. This is Lupin's first product using Nanomi B.V.'s technology and has a 180-day CGT exclusivity.
"Risperidone's U.S. FDA approval provides crucial validation of Nanomi's LAI technology platform and testifies to Lupin's ability to bring complex injectables to market," said Shahin Fesharaki, Chief Scientific Officer of Lupin.
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