The Fluoroquinolone Toxicity Research Foundation

For those who have an interest in the FDA history of levaquin approvals

LEVAQUIN® (levofloxacin) Presentation to AIDAC October 20, 1999 ... 12/1/99. Click here to start. Table of Contents. LEVAQUIN® (levofloxacin) Presentation to AIDAC October 20, 1999. FDA Approval: December 20, 1996..
http://www.fda.gov/ohrms/dockets/ac/99/slides/3558s1d/

020634s04 Levaquin (Levofloxacin) Tablets & Injection Levaquin (Levofloxacin) Tablets & Injection Company: RW Johnson Application No.: 020634/S04 & 0202635/S03 Approval Date: 12/17/1998.
http://www.fda.gov/cder/foi/nda/98/020634s04.htm

FDA Drug Approvals List September 2000
08-SEP-00 Trade Name: LEVAQUIN Dosage Form: TABLET Applicant ... To Original New Drug
Application Approval Date: 01-SEP-00 ... 08, 2001 http://www.fda.gov/cder/da/da0900.htm

FDA Drug Approvals List December 1998
... 17-DEC-98 Trade Name: LEVAQUIN Dosage Form: TABLET Applicant ... Original New Drug Application
Approval Date: 01-DEC-98 ... 19., 1999 http://www.fda.gov/cder/da/da1298.htm

FDA Drug Approvals List February 2000
... 02-FEB-00 Trade Name: LEVAQUIN Dosage Form: TABLET Applicant ... To Original New Drug
Application Approval Date: 02-FEB-00 ... 08, 2001 http://www.fda.gov/cder/da/da0200.htm

NDA 20-634/S-008, S-009 NDA 20-635/S-007, S-008 The RW ...
... for LEVAQUIN Tablets and LEVAQUIN Injection. We acknowledge receipt of ... S-007, S-008." Approval of these submissions by FDA is not required before ...
http://www.fda.gov/cder/foi/appletter/2000/20635S7,8LTR.PDF

Reference Listed Drug Labeling Approved in December 2001
... levofloxacin tablets, 20-635. S-020. LEVAQUIN, letter, label, levofloxacin injection, ... Approval Date, Trade Name. Active Ingredient(s ... FDA/Center for Drug Evaluation and ...
http://www.fda.gov/cder/ogd/rld/rld_labeling_approved_dec
_2001.htm

DEPARTMENT OF HEALTH & HUMAN SERVICES NDA 20-634/S-025 NDA 20 ...
... provide for the use of Levaquin Tablets and Injection for the ... NDA 20-635/S-022." Approval of these submissions by FDA is not required before the ...
http://www.fda.gov/cder/foi/appletter/
2002/20634se1-025,20635se1-022ltr.pdf

Application Number : 020635 Trade Name : LEVAQUIN INJECTION ... ... Number : 020635 Trade Name : LEVAQUIN INJECTION Generic Name: Levofloxacin ... approved NDA 20-635. Approval of this submission ~ FDA is not required before ...
http://www.fda.gov/cder/foi/nda/96/020635ap.pdf

Reference Listed Drug Labeling Approved in September 2000
... approved labeling or the supplemental approval letter describing the specific changes ... LEVAQUIN, levofloxacin injection, 20-635/S ... FDA/Center for Drug Evaluation and ... http://www.fda.gov/cder/ogd/rld/rld_labeling_
approved_september_2000.html

NDA 20-634/S-013 NDA 20-635/S-010 The RW Johnson ...
... provide for the use of LEVAQUIN ® for the treatment of complicated ... NDA 20-635/S-010." Approval of these submissions by FDA is not required before ...
http://www.fda.gov/cder/foi/appletter/2000/20635S10ltr.pdf

Reference Listed Drug Labeling Approved in February 2000
... approved labeling or the supplemental approval letter describing the specific ... Johnson RW, 2. LEVAQUIN, Levofloxacin tabs, 20-634/S ... FDA/Center for Drug Evaluation ...
http://www.fda.gov/cder/ogd/rld/RLD_LABEL_APPROVED
_FEB_2000.HTML

DEPARTMENT OF HEALTH & HUMAN SERVICES ...
... the following changes to the Levaquin ® pakage insert. The deleted text ... S-019, S-020." Approval of these submissions by FDA is not required before ...
http://www.fda.gov/cder/foi/appletter/2001/20634s15s21s22ltr.pdf

Drug Approvals - L
Product Name, Company, Application #, Approval Date, Letter Posted. Label Posted, Review Posted. ... Levaquin, Rx, RW Johnson, NDA 20-634, S004 & 20-635, S003, 12/17 ...
http://www.fda.gov/cder/approval/l.htm

RLD_LABELING_APPROVED_JUL_1999
... labeling or the supplemental approval letter describing the specific ... 29-Jul-1999. LEVAQUIN, Levofloxacin tablets, 20-634. S ... [http://www.fda.gov/cder/cderbar.htm]. ...
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED
_JUl_1999.HTML

Reference Listed Drug Labeling Approved in October 2002
... Approval. Date. Product Name. Source Documents, Active ... Oct 30, LEVAQUIN, letter, label, levofloxacin injection, 20-635, SE1 ... FDA/Center for Drug Evaluation and Research ...
http://www.fda.gov/cder/ogd/rld/rld_labeling_approved
_october_2002.htm

NDA 20-634/S-015, S-021, S-022 NDA 20-635/S-012, S-019, S-020 ... ... the following changes to the Levaquin ® pakage insert. The deleted text ... S-019, S-020." Approval of these submissions by FDA is not required before ...
http://www.fda.gov/cder/foi/appletter/2001/20365s20ltr.pdf

Drug Approvals December 1996
... 20-DEC-96 Trade Name: LEVAQUIN Chemical Type: 3 Therapeutic ... To Original New Drug Application
Approval Date: 03-DEC-96 ... 1, 1997 http://www.fda.gov/cder/da/da1296.htm

1996 and Older - New Drug Application (NDA)
... These drug approval packages, sorted by product ... the product name to view the approval packages in Adobe Acrobat format. For ... Levaquin/Levofloxacin Part 1 [8 MB ...
http://www.fda.gov/cder/foi/nda/index96.htm

Efficacy Supplements Approved in Calendar Year 2003 (SE1-SE7 ... ... GENERIC NAME, APPLICANT, NDA NUMBER, ... DATE, PRIORITY REVIEW, TOTAL APPROVAL TIME (MONTHS),
INDICATION/DESCRIPTION. ... for the use of Levaquin Tablets for the treatment of ...
http://www.fda.gov/cder/rdmt/ESCY03AP.HTM

Tequin Consumer Information
... Approved by FDA: December 17, 1999. *Approval by FDA does not mean that the ... such as Cipro (ciprofloxacin) or Levaquin (levofloxacin). have a rare condition ...
http://www.fda.gov/cder/consumerinfo/druginfo/tequin.htm

Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 ... ... GENERIC NAME, APPLICANT, NDA NUMBER, SUPP ... 02 **, 10.6, Provides a tentative approval
for the use of Follistim ... for the use of Levaquin Tablets for the treatment of ...
http://www.fda.gov/cder/rdmt/ESCY02AP.HTM

September 2000 Safety-Related Drug Labeling Changes
... CHANGES APPROVED BY FDA September 2000. ... flush), LAMICTAL (lamotrigene), LEVAQUIN (levofloxacin), LUVOX (fluvoxamine ... identified during post-approval use of Flolan ...
http://www.fda.gov/medwatch/safety/2000/sep00.htm

Developing Drugs for Resistant Pathogens
... Table 3 (cont.) October 1999 Levaquin (levofloxacin) IV/PO Penicillin ... survival or irreversible morbidity. FDA may grant marketing approval for a new drug ...
http://www.fda.gov/ohrms/dockets/ac/02/briefing/
3837b2_01_Resistance.pdf

EFFICACY SUPPLEMENTS APPROVED IN CY 2000
... GENERIC NAME, APPLICANT, NDA NUMBER, ... SUPP NUMBER, PRIORITY REVIEW, TOTAL APPROVAL
TIME (MONTHS), INDICATION/DESCRIPTION. ... for the use of LEVAQUIN for the treatment of ...
http://www.fda.gov/cder/rdmt/esap2000.htm

Resistance Outline
... Levaquin. ... FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug ...
http://www.fda.gov/ohrms/dockets/ac/02/briefing/
3837b2_01_Resistance.doc

MedWatch - October 2002 Safety-Related Drug Labeling Changes
... Labeling provides for the use of Levaquin Tablets and Injection for the treatment ... not in 2002 PDR: http://www.fda.gov/medwatch/SAFETY/2002/oct02.htm

This transcript has not been edited corrected, but appears ...
... Questions to the Advisory Committee . . LEVAQUIN Public Comment: Dr. David Bell . . . . . FDA Introduction, Mark Goldberger, MD CDC Presentation ...
http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3558t1a.pdf

Document Information Page
... NDA 21-061/S-007, NDA 21-062/S-006, NDA 21-062/S-007, and NDA 21-062/S-008." Approval of these submissions by FDA is not required before the labeling is used. ...
http://www.fda.gov/cder/foi/label/2001/21062s8lbl.pdf

NDA 20-634/S-013 NDA 20-635/S-010 The RW Johnson ...
... provide for the use of LEVAQUIN ® for the treatment of complicated ... NDA 20-635/S-010."
Approval of these submissions by FDA is not required before ...
http://www.fda.gov/cder/ogd/rld/20635s10.pdf

1 back to the other point though. If you had two ...
Page 1. 1 back to the other point though ... www.nealrgross.com
Page 2. 1 2 3 4 ...
http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3558t1b.pdf

1 .FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG ...
... Women's Health Project. I'm a consumer representative guest. 7 With respect to FDA's invited guests and guest speakers, Dr. Gideon Koren and Ms. Julia Scott ...
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3645t1.pdf

1 comments about it, but certainly we are interested in ...
... makes sense is based on two things: one, that the overall resistance to Levaquin is very low; and the other, that Levaquin resistance and penicillin resistance ...
http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3558t1d.pdf

EXECUTIVE SUMMARY
... FDA Briefing Package - January 8, 2003 AIDAC meeting. NDA ... on February 28, 2000. The Applicant requested approval for marketing of telithromycin in the United ...
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3919B1_02_B-FDA%20Master%20Copy.pdf

EXECUTIVE SUMMARY
... 2002 NDA Amendment, 4 of which were those recommended by the FDA in the June 2001 approval letter. The following is a summary of the clinical pharmacology / PK ...
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3919B1_02_B-FDA%20Master%20Copy.htm

EXECUTIVE SUMMARY
... 2002 NDA Amendment, 4 of which were those recommended by the FDA in the June 2001 approval letter. The following is a summary of the clinical pharmacology / PK ...
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3919B1_02_B-FDA%20Master%20Copy.doc

FOOD AND DRUG ADMINISTRATION. CENTER FOR ... a few months later the FDA action letter
that followed asking ... when we're considering drug approval, and that is safety. ...
http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3919T1.doc

... FOOD AND DRUG ADMINISTRATION. CENTER ...
a few months later the FDA action letter that
followed asking ... when we're considering drug approval, and that is safety. ...
http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3919T1.htm

... The sponsor is requesting approval for the use of LEVAQUIN (Ievofloxacin) tablets for the ... Protocol M92-040: For FDA clinically evaluable patients, clinical ...
http://www.fda.gov/cder/foi/nda/96/020634-4.pdf

somebody either walks into the clinician's office with a ...
Page 1. 1 2 3 4 somebody either walks into ... 3701 www.nealrgross.com Page 2. 1 add to our ...
http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3558t1c.pdf

... LEVAQUIN. Public Comment: Dr. David Bell ... This concept is described in FDA Modernization
Act, and also ... maybe if we have approval for other serious infections or ...
http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3558t1.rtf

Untitled
... Drug, and Cosmetic Act for Levaquin" (levofloxacin) 250- and 500- mg ... for approved
NDA 20-634. Approval of t.hk submission by.FDA is not required before the ...
http://www.fda.gov/cder/foi/nda/96/020634-1.pdf

FDA Briefing Package
http://www.fda.gov/ohrms/dockets/ac/01/briefing/
3746b_02_FDA.htm

1 DEPARTMENT OF HEALTH AND HUMAN SERVICES
... have 19 some additional interaction between FDA, IDSA and 20 PhRMA. The feeling ... additional
6 discussion on standards for approval of new 7 products, a ...
http://www.fda.gov/ohrms/dockets/dockets/02n0461/02n-0461-tr00001-vol3.pdf

FDA Briefing Package
... Efficacy: The applicant has requested approval for telithromycin in adults for ... and
sinusitis. Requests to the FDA regarding marketing claims for infections ...
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3919B1_02_C-FDA%20Appendix%20A.pdf

FDA Briefing Package
... Efficacy: The applicant has requested approval for telithromycin in adults for ... and sinusitis. Requests to the FDA regarding marketing claims for infections ...
http://www.fda.gov/ohrms/dockets/ac/01/briefing/
3746b_02_FDA.pdf

SAG CORP. 1 UNITED STATES OF AMERICA FOOD AND DRUG ...
... July meeting 16 was a meeting between FDA and largely with industry to 17 get ... beginning
with Synercid in 16 1998, Levaquin in October of '99, Zyvox in ...
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3837t2.pdf

FDA Briefing Package
... Efficacy: The applicant has requested approval for telithromycin in adults for the ... Requests to the FDA regarding marketing claims for infections due to ...
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3919B1_02_C-FDA%20Appendix%20A.doc

FDA Briefing Package
... Efficacy: The applicant has requested approval for telithromycin in adults for the ... Requests to the FDA regarding marketing claims for infections due to ...
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3919B1_02_C-FDA%20Appendix%20A.htm

1 FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION ...
... of 2001, a few months later the FDA action letter that 1 followed asking for ... equation
when we're considering drug approval, 23 and that is safety. 24 ...
http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3919T1.pdf

... of Drug Evaluation for the FDA. Gary. ... 99 to discuss supplemental application for
Levaquin for the treatment of penicillin ... this sponsor is requesting approval. ...
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3597t1.rtf

... with Synercid in 1998, Levaquin in October of '99 ... early consultation between the
FDA and pharmaceutical sponsors as ... provides for earlier approval in the drug ...
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3837t2.doc

1 DEPARTMENT OF HEALTH AND HUMAN SERVICES
... 19 some section poses certain problems for FDA for the 20 reasons we talked ... 8 intermittently
yesterday of an accelerated 9 approval. 10 In spite of the ...
http://www.fda.gov/ohrms/dockets/dockets/02n0461/02n-0461-tr00002-vol3.pdf

... way of background, we know that Levaquin was approved for treatment of ... the prototypic drug should receive FDA approval under provisions that currently ...
http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3456t2.rtf