China-based international pharmaceutical company Luye Pharma Group (Luye Pharma) announced on Sunday that it has received approval from the US Food and Drug Administration (FDA) for its ERZOFRI (paliperidone palmitate) extended-release injectable suspension, intended for the treatment of schizophrenia in adults and for treating schizoaffective disorder in adults, as monotherapy and as an adjunct to mood stabilisers or antidepressants.
ERZOFRI is administered once a month and is the first patented paliperidone palmitate long-acting injection produced in China to receive approval in the US.
ERZOFRI received a US patent (Patent No.11,666,573) in 2023, which expires in 2039. It is approved as a new drug under the 505(b) (2) pathway in the US.
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