REGADENOSON | N022161 | ASTELLAS PHARMA US INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-06-25 | Terminated 2021-08-18 | — | |
| D. Del. | 2018-10-25 | Terminated 2022-06-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from IDRS Labs Private Limited FDA-2021-P-0389 IDRS Labs Private Limited filed this citizen petition pursuant to 21 C.F.R. § 10.30 and section 505(q) of the FD&C Act requesting that the FDA require any ANDA filer seeking approval for a generic version of Lexiscan (regadenoson for injection, 0.4 mg/5 mL) to use a plastic prefilled syringe packagi | 505(q) | 2021-04-15 | Denied | IDRS Labs Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.