LUYE INNOMIND PHARMA — Erzofri FDA Review (NDA216352, ORIG 1, 2024)
LUYE INNOMIND PHARMA · 2024 · FDA Review (openFDA) · company profile →
Report summary
The FDA recommends approval for Erzofri (Paliperidone palmitate ER) injectable suspension (NDA 216352) for schizophrenia and schizoaffective disorder. This recommendation is based on comprehensive multidisciplinary reviews, including nonclinical, clinical pharmacology, and safety assessments. Erzofri's safety and pharmacokinetic profiles are comparable to the listed drug, Invega Sustenna, supported by bridging studies (e.g., Study 103). While no new efficacy studies were conducted, reliance on Invega Sustenna's established efficacy is justified. Common adverse events include weight gain, somnolence, and extrapyramidal symptoms, consistent with the listed drug. The manufacturing processes and proposed dosing regimen are deemed adequate.
Key findings — cited to the page
| Priority or Standard | Standard | · p.2 |
| Submit Date | 9/26/2023 | · p.2 |
| Received Date | 9/26/2023 | · p.2 |
| PDUFA Goal Date | 7/26/2024 | · p.2 |
| Review Completion Date | 07/26/2024 | · p.2 |
| Applicant | Luye Innomind Pharma Shijiazhuang Co., Ltd. | · p.2 |
| Proposed Indication - Schizophrenia Initiation Dosing (Day 1) | 351 mg | Erzofri · p.2 |
| F2 ~ injection site relationship (FINJS) | 1.47 | · p.121 |
| Ratio of F2 between LD and LY03010 (R_F2) | 0.684 | · p.121 |
| Ratio for F2 relative to injection site (R_FINJS) | 2.07 | · p.121 |
| Ratio for D2 (R_D2) | 1.05 | · p.121 |
| EPS (IDR) | 5 % | · p.97 |
Source: LUYE INNOMIND PHARMA ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →