| | | | | | | | | | |
| Dockets Management
|
|
| Dockets Entered On
July 28, 2006
Table of Contents
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1999E-5113
|
| Patent Extension: Clinacox (diclazuril), #4,631,278
|
| |
|
|
| 2003E-0418
|
| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
|
| |
|
|
| 2005D-0169
|
| Guidance on Useful Written Consumer Medication Information (CMI)
|
| |
|
|
| 2005E-0250
|
| Patent Term Extension Application for NSURE U.S. Patent No. 4,600,706
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| 2006E-0189
|
| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
|
| |
|
|
| 2006E-0261
|
| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
|
| |
|
|
| 2006N-0051
|
| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
|
| |
|
|
| 2006N-0202
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
|
| 2006P-0093
|
| ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128-409, Merial LTD.,
|
|
|
|
|
|
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
| |
|
|
| 2006P-0159
|
| Recommend changes to NIST Handbook 44 (through the NIST and NCWM), and the U.S. Pharmacopeia to reflect the required pharmacy quality control practices
|
| |
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
| |
|
|
| 2006P-0280
|
| Emergency Request to Open Blood Products Advisory Committee Meeting on Friday, July 14, 2006
|
| |
|
|
| 2006P-0287
|
| determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| 2006P-0299
|
| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
|
| |
|
|
| 2006P-0300
|
| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
|
| |
|
|
| 1999E-5113
|
| Patent Extension: Clinacox (diclazuril), #4,631,278
|
| |
|
|
| LET 5
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0418
|
| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
|
| |
|
|
| LET 4
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2005D-0169
|
| Guidance on Useful Written Consumer Medication Information (CMI)
|
| |
|
|
| EC 18
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0250
|
| Patent Term Extension Application for NSURE U.S. Patent No. 4,600,706
|
| |
|
|
| LET 2
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 17953
|
| D. Briggs
|
| Vol #:
|
| 193
|
| |
|
|
| C 17954
|
| S. Hodas
|
| Vol #:
|
| 193
|
| |
|
|
| C 17955
|
| R. Morse
|
| Vol #:
|
| 193
|
| |
|
|
| C 17956
|
| L. Semple
|
| Vol #:
|
| 193
|
| |
|
|
| C 17957
|
| T. Mardorf
|
| Vol #:
|
| 193
|
| |
|
|
| C 17958
|
| E. Kelley
|
| Vol #:
|
| 193
|
| |
|
|
| C 17959
|
| S. Haughy
|
| Vol #:
|
| 193
|
| |
|
|
| C 17960
|
| M. McCravy
|
| Vol #:
|
| 193
|
| |
|
|
| C 17961
|
| C. Skousen
|
| Vol #:
|
| 193
|
| |
|
|
| C 17962
|
| C. Lambert
|
| Vol #:
|
| 193
|
| |
|
|
| C 17963
|
| L. Trounig
|
| Vol #:
|
| 193
|
| |
|
|
| C 17964
|
| S. Minor
|
| Vol #:
|
| 193
|
| |
|
|
| EC 33257
|
| Ms. Patti Shaffner,LDH
|
| Vol #:
|
| 142
|
| |
|
|
| EC 33258
|
| Ms. Sandra M. Goguen
|
| Vol #:
|
| 142
|
| |
|
|
| 2006E-0189
|
| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
|
| |
|
|
| LET 4
|
| FDA/CDER to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0261
|
| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
|
|
|
| LET 2
|
| FDA/CDER to U.S. Patent and Tradmark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0051
|
| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
|
| |
|
|
| EC 2
|
| OPTN/UNOS
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0202
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
|
|
| |
|
|
| EC 1
|
| Tracon Consultants Ltd.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Tracon Consultants Ltd.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0093
|
| ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128-409, Merial LTD.,
|
|
|
|
|
|
|
| |
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
| | | | | | | | |
| |
|
|
| EC 670
|
| National Organization for Women
|
| Vol #:
|
| 3
|
| |
|
|
| EC 671
|
| Ms. Judy Trompeter
|
| Vol #:
|
| 3
|
| |
|
|
| EC 672
|
| Ms. Gayle` Kaplan
|
| Vol #:
|
| 3
|
| |
|
|
| EC 673
|
| Ms. Kelly Angel
|
| Vol #:
|
| 3
|
| |
|
|
| EC 674
|
| Ms. Alison Spears
|
| Vol #:
|
| 3
|
| |
|
|
| 2006P-0159
|
| Recommend changes to NIST Handbook 44 (through the NIST and NCWM), and the U.S. Pharmacopeia to reflect the required pharmacy quality control practices
|
| |
|
|
| PDN 1
|
| FDA/CDER to James Q. Maloy
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
| |
|
|
| EC 12
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0280
|
| Emergency Request to Open Blood Products Advisory Committee Meeting on Friday, July 14, 2006
|
| |
|
|
| WDL 1
|
| Public Citizen Litigation Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0287
|
| determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0299
|
| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
|
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0300
|
| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
|
| |
|
|
| ACK 1
|
| FDA/DDM to Lachman Consultant Services Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consultant Services Inc.
|
| Vol #:
|
| 1
|
|
|
