BPI LABS, LLC v. FOOD AND DRUG ADMINISTRATION et al
| BPI LABS, LLC |
| FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, XAVIER BECERRA and ROBERT M. CALIFF, M.D. |
| 1:2024cv00966 |
| April 4, 2024 |
| US District Court for the District of Columbia |
| Administrative Procedure Act/Review or Appeal of Agency Decision |
| 05 U.S.C. ยง 0701 Judicial Review of Agency Decision |
| None |
Docket Report
RSS Track this Docket
This docket was last retrieved on April 4, 2024. A more recent docket listing may be available from PACER.
| Document Text |
|---|
| Filing 1 COMPLAINT against All Defendants ( Filing fee $ 405 receipt number ADCDC-10806629) filed by BPI LABS, LLC. (Attachments: #1 Exhibit Exhibit 1 - FDA Stay of Approval BPI Labs, #2 Exhibit Exhibit 2 - FDA approved Package Insert for Epinephrine Injection USP, 1 MgMl (1 1000), #3 Exhibit Exhibit 3 - Tentative Approval NDA-205029-SUPPL-13-RESUB-126_Upload Final Decision_Tentative Approval, #4 Exhibit Exhibit 4 - Final Approval NDA-205029-SUPPL-13-RESUB-126_Final Decision_Approved, #5 Exhibit Exhibit 5 - April 3 2024 EndoPar Letter to Taras Gracey, #6 Exhibit Exhibit 6 - Ex Parte Communications btwn FDA and Endo Par, #7 Exhibit Exhibit 7 - FDA email to BPI NDA 205029 Stay of Approval Letter, #8 Exhibit Exhibit 8 - Endo Preliminary Injunction Motion, #9 Civil Cover Sheet Civil Cover Sheet, #10 Summons Summons - Becerra, #11 Summons Summons - Califf, #12 Summons Summons - FDA, #13 Summons Summons - HHS)(Smith, Scott) |
Access additional case information on PACER
Use the links below to access additional information about this case on the US Court's PACER system. A subscription to PACER is required.
Access this case on the District Of Columbia District Court's Electronic Court Filings (ECF) System
- Search for Party Aliases
- Associated Cases
- Attorneys
- Case File Location
- Case Summary
- Docket Report
- History/Documents
- Parties
- Related Transactions
- Check Status
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
