OSMOTICA PHARM US — Relexxii FDA Review (NDA216117, ORIG 1, 2022)
OSMOTICA PHARM US · 2022 · FDA Review (openFDA)
Report summary
The FDA's multi-disciplinary review of Osmotica Pharmaceutical US LLC's New Drug Application (NDA 216117) for Relexxii, an extended-release methylphenidate HCl tablet, is detailed in this report. The 505(b)(2) application sought approval for 45 mg and 63 mg strengths for ADHD treatment in adults and pediatric patients aged 6 years and older. Relying on bioequivalence to Concerta and established efficacy/safety, the FDA recommended approval.
Key findings — cited to the page
| Application Type | 505(b)(2) | Relexxii · p.2 |
| Application Number | NDA 216117 | Relexxii · p.2 |
| PDUFA Goal Date | June 23, 2022 | Relexxii · p.2 |
| Review Completion Date | June 23, 2022 | Relexxii · p.2 |
| Proposed Indication | Attention Deficit Hyperactivity Disorder (ADHD) | Relexxii · p.2 |
| Recommended Indication | Treatment of attention deficit hyperactivity disorder in adults (up to the age of 65 years) and pediatric patients 6 years of age and older | Relexxii · p.2 |
| Regulatory Action Recommendation | Approval | Relexxii · p.2 |
| Dosage form strengths | 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63mg, 72 mg mg | Relexxii · p.2 |
| Recommended Dosing Regimen (Pediatric 6-12 years) | 18 to 54 mg once daily mg | Relexxii · p.2 |
| Recommended Dosing Regimen (Pediatric 13-17 years) | 18 to 72 mg once daily mg | Relexxii · p.2 |
| Recommended Dosing Regimen (Adults) | 18 to 72 mg once daily mg | Relexxii · p.2 |
| Listed Drug (LD) for 505(b)(2) application | Concerta (NDA 021121) | Relexxii · p.5 |
Source: OSMOTICA PHARM US ↗ · 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 →