Replies to post #111624 on Biotech Values

[mouton29]

It is early, not late February for the FDA to answer the Amphaster complaint.

Here is a cut and paste of the docket:

TYPE-D
U.S. District Court
District of Columbia (Washington, DC)
CIVIL DOCKET FOR CASE #: 1:10-cv-01800-RMU


AMPHASTAR PHARMACEUTICALS, INC. v. FOOD AND DRUG ADMINISTRATION et al
Assigned to: Judge Ricardo M. Urbina
Cause: 05:0706 Judicial Review of Agency Actions
Date Filed: 10/25/2010
Jury Demand: None
Nature of Suit: 890 Other Statutory Actions
Jurisdiction: U.S. Government Defendant
Plaintiff
AMPHASTAR PHARMACEUTICALS, INC. represented by Anthony Tobias Pierce
AKIN GUMP STRAUSS HAUER & FELD LLP
1333 New Hampshire Ave, NW
Washington, DC 20036
[phone]
Fax: [phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

V.
Defendant
FOOD AND DRUG ADMINISTRATION represented by Gerald Cooper Kell
U.S. DEPARTMENT OF JUSTICE
Civil Division, Office of Consumer Litigation
P.O. Box 386
Washington, DC 20044
[phone]
Fax: [phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED
Defendant
MARGARET A. HAMBURG
M.D. - Commissioner of Food and Drugs represented by Gerald Cooper Kell
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED
Defendant
KATHLEEN SEBELIUS
Secretary of Health and Human Services represented by Gerald Cooper Kell
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Date Filed # Docket Text
10/25/2010 1 COMPLAINT against FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS ( Filing fee $ 350, receipt number 4616033675) filed by AMPHASTAR PHARMACEUTICALS, INC.. (Attachments: # 1 Civil Cover Sheet)(jf, ) (Entered: 10/26/2010)
10/25/2010 SUMMONS (5) Issued as to FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS, U.S. Attorney and U.S. Attorney General. (jf, ) (Entered: 10/26/2010)
10/25/2010 2 LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests NONE by AMPHASTAR PHARMACEUTICALS, INC. (jf, ) (Entered: 10/26/2010)
10/26/2010 3 NOTICE of Appearance by Gerald Cooper Kell on behalf of All Defendants (Kell, Gerald) (Entered: 10/26/2010)
11/05/2010 4 WITHDRAWN PURSUANT TO NOTICE FILED 11/12/2010.....MOTION for Preliminary Injunction by AMPHASTAR PHARMACEUTICALS, INC. (Attachments: # 1 Declaration Declaration of Stephen A. Campbell, # 2 Exhibit Exhibit 1, # 3 Exhibit Exhibit 2, # 4 Exhibit Exhibit 3, # 5 Exhibit Exhibit 4, # 6 Exhibit Exhibit 5, # 7 Exhibit Exhibit 6, # 8 Exhibit Exhibit 7, # 9 Exhibit Exhibit 8, # 10 Exhibit Exhibit 9, # 11 Exhibit Exhibit 10, # 12 Exhibit Exhibit 11, # 13 Exhibit Exhibit 12, # 14 Exhibit Exhibit 13, # 15 Exhibit Exhibit 14, # 16 Exhibit Exhibit 15, # 17 Exhibit Exhibit 16, # 18 Exhibit Exhibit 17, # 19 Text of Proposed Order Proposed Order)(Pierce, Anthony) Modified on 11/12/2010 (tg, ). Modified on 11/15/2010 (znmw, ). (Entered: 11/05/2010)
11/12/2010 5 NOTICE OF WITHDRAWAL OF MOTION by AMPHASTAR PHARMACEUTICALS, INC. re 4 MOTION for Preliminary Injunction (Pierce, Anthony) (Entered: 11/12/2010)
12/22/2010 6 Consent MOTION for Leave to File an Amended Complaint by AMPHASTAR PHARMACEUTICALS, INC. (Attachments: # 1 Proposed Amended Complaint, # 2 Stipulated Extension of Time for Defendants to Respond to Amended Complaint, # 3 Text of Proposed Order)(Pierce, Anthony) (Entered: 12/22/2010)
12/23/2010 MINUTE ORDER granting 6 motion for leave to file. Upon consideration of the plaintiff's consent motion for leave to file an amended complaint, the it is hereby ORDERED the motion is GRANTED; and it is FURTHER ORDERED that the defendants shall respond to the plaintiff's amended complaint on or before February 2, 2011. SO ORDERED. Signed by Judge Ricardo M. Urbina on 12/23/10. (EN, ) (Entered: 12/23/2010)
12/23/2010 Set/Reset Deadlines: Defendants' answer to the amended complaint due by 2/2/2011 (tg, ) (Entered: 12/23/2010)
12/23/2010 7 AMENDED COMPLAINT against FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS filed by AMPHASTAR PHARMACEUTICALS, INC..(jf, ) (Entered: 12/27/2010)