REF PRODUC DATE
`
`DESCRIPTION
`
`SERI PROTOCOL SUBMISSION TYPE
`
`52,003 Certican® 08/09/2005 TELECON confirming meeting scheduled with FDA for
`August 22, 2005, to discuss protocol A2310 with modeling
`simulations.
`
`Memo of Record (telephone
`report)
`
`52,003 Certican® 0810512005
`
`52,003 Certican® 0810512005
`
`52,003 Certican® 0810312005
`
`[GREAT BRITAIN) Dr. Ian Judson: Gastrointestinal
`haemorrhage, bone marrow depression, cardiac arrest,
`malignant neoplasm progression, melaena, vomiting,
`haemoglobin decreased, platelet count decreased,
`dyspnoea, abdominal pain, loss of consciousness;
`Follow-up#3
`
`[AUSTRALIA] Dr. Dan Chambers: Vasculitis
`gastrointestinal, laukocytoclastic vasculitis, dermatitis
`allergic, neutropenia, white blood cell countdecreased,
`diarrhoea, vomiting, intestinal ischaemia, biopsy colon
`abnormal, petechiae, biopsy skin abnormal: Follow-up#1
`
`[AUSTRALIA] Dr. Dan Chambers: Vasculitis
`gastrointestinal, leukocytoclastic vasculitis, dermatitis
`allergic, neutropenia, white blood cell count decreased,
`diarrhoea, vomiting, intestinal ischaemia, biopsy intestine
`abnormal, biopsy colon abnormal, petechiae, biopsy skin
`abnormal.
`
`382 2101
`
`Safety Report
`
`381
`
`Safety Report
`
`380
`
`Safety Report
`
`52,003 Certican® 0810212005 FDA FAX containing minutes from telecon of July 21, 2005.
`FDA also addressed NVS request for a follow-up
`teleconference to discuss the heart protocol (A2310).
`
`FDA/Novartis Meeting MinU'
`
`52,003 Certican® 07/0612005 Dr. Judith Wolf: Hyperglycaemia; Follow-up#1.
`
`378 C2409
`
`Safety Report
`
`52,003 Certican® 07/01/2005 Dr. L. Miller: Cardiac tamponade, anastomotic leak,
`unresponsive to verbal stimuli, fall, cardiac arrest,
`accelerated idioventrlcular rhythm; Follow-up#5
`
`377 A2403
`
`Safety Report
`
`52,003 Certican® 06/30/2005
`
`[GREAT BRITAIN] Prof. Ian Judson: Cryptogenic
`organizing pneumonia, lung infiltration, dyspnoea, dyspnoea
`exertional; Follow-up#1
`
`376 2101
`
`Safety Report
`
`52,003 Certican® 06/2712005 This submission provides a point-by-point response to the
`Division's comments for study CRAD001A2310 submitted
`February 4, 2005.
`
`52,003 Certican® 0612212005 New Protocol to Study No. CRAD001 A2309 entitled, ftA
`24-Month, multicenter, randomized, open-label
`non-inferiority study of efficacy and safety comparing
`concentration-controlled Certican in two doses (1.5 and 3.0
`mg/day starting doses) with reduced Neoral versus 1.44 g
`Myfortic with standard dose of Neoral in de nova renal
`transplant patients.
`
`52,003 Certican® 06/21/2005
`
`[AUSTRALIA J Dr. Josette Eris: Drug exposure during
`pregnancy, premature rupture of membranes, normal
`delivery, hypertension; Follow-up#1.
`
`375
`
`Clinical Information Amendr
`
`·
`
`374 A2309
`
`New Protocol
`
`373 A2307
`
`Safety Report
`
`52,003 Certican® 06/0812005 Howard Burris, MD: Mental status changes, anaemia.
`
`372 2101
`
`Safety Report
`
`52,003 Certican® 0610312005 TELECON with FDA in order to schedule a telecon on
`21-Jul-2005 to discuss protocol A2310 (heart) statistical
`model and simulations for exposures. The Division will also
`respond to NVS proposals on A2309 (kidney) at the same
`. time.
`
`Memo of Record (telephone
`report)
`
`52,003 Certican® 06/0212005 Dr. L. Miller: Cardiac tamponade, anastomotic leak,
`unresponsive to verbal stimuli, fall, cardiac arrest,
`accelerated idioventricular rhythm; Follow-up#4.
`
`371 A2403
`
`Safety Report
`
`
`
`

`
`REF PRODUC DATE
`
`DESCRIPTION
`
`52,003 Certican® 0610212005
`
`52,003 Certican® 06101/2005
`
`52,003 Certican® 06101/2005
`
`52,003 Certican® 05131/2005
`
`[GREAT BRITAIN] Dr. Ian Judson: Gastrointestinal
`haemorrhage, bone marrow depression, circulatory
`collapse, cardiac arrest, malignant neoplasm progression,
`melaena, vomiting, haemoglobin decreased, platelet count
`decreased, dyspnoea, abdominal pain, loss of
`consciousness; Follow-up#2.
`[AUSTRALIA I Dr. Steve Chadban: Drug exposure during
`pregnancy, cerebral ventricle dilatation, renal disorder,
`umbilical cord vascular disorder.
`
`[AUSTRALIA] Dr. Josette Eris: Drug exposure during
`pregnancy, premature rupture of membranes, normal
`delivery, hypertension.
`
`[GREAT BRITAIN J Dr. Ian Judson: Gastrointestinal
`haemorrhage, bone marrow depression, circulatory
`collapse, cardiac arrest, malignant neoplasm progression,
`melaena, vomiting, haemoglobin decreased, platelet count
`decreased, dyspnoea, abdominal pain, loss of
`consciousness; Follow-up#1.
`
`SERI PROTOCOL SUBMISSION TYPE
`
`370 2101
`
`Safety Report
`
`369 2307E1
`
`Safety Report
`
`368 A2307
`
`Safety Report
`
`367 2101
`
`Safety Report
`
`52,003 Certican® 05126/2005
`
`( SWITZERLAND J Dr. D. Uehlinger: Eye haemorrhage,
`Retinal detachment, eye operation; Follow-up#1.
`
`366 A2307
`
`Safety Report
`
`52,003 Certican® 0512012005 Response to request to provide questions for discussion on
`study CRAD001A2301.
`
`365
`
`Response to FDA Request
`
`52,003 Certican® 05119/2005 This Annual Report covers the period November 15, 2003
`through November 14, 2004. Includes clinical study
`information, preclinical study information, Farelgn marketing
`developments and outstanding regulatory business.
`
`364
`
`Annual Report
`
`52,003 Certican® 05/1612005 Dr. L. Miller: Cardiac tamponade, anastomotic leak,
`unresponsive to verbal stimuli, fall, cardiac arrest,
`accelerated idloventricular rhythm; Follow-up#3.
`
`363 2403
`
`Safety Report
`
`52,003 Certican® 05/1312005 Point-by-point response to the Division's comments for
`Study CRAD001A2309.
`
`362
`
`Response to FDA Request
`
`52,003 Certican® 0511212005 Richard Stone. MD: Interstitial lung disease, pneumonitis,
`nausea, drug interaction potentiation, dyspnoea, hypoxia,
`pleural effusion, performance status decreased, cough,
`pulmonary fibrosis; Follow-up#1.
`
`361 2207
`
`Safety Report
`
`52,003 Certican® 05/1212005 Amendment No. 4 to Study No. CRAD001AUS09.
`
`360 US09
`
`Change In Protocol
`
`52,003 Certican® 0511112005 Richard Stone. MD: Pneumonia, diarrhoea, dyspnoea,
`hypoxia, pleural effusion, crackles lung; Follow-up#1
`
`359 2207
`
`Safety Report
`
`52,003 Certican® 05/0612005
`
`[ SWITZERLAND ] Dr. D. Uehlinger: Eye haemorrhage,
`retinal detachment, eye operation.
`
`358 2307E1
`
`Safety Report
`
`52,003 Certican® 05/06/2005 Richard Stone: Pneumonia, hypoxia, diarrhoea, pleural
`effusion! dyspnoea, crackles lung.
`
`357 2207
`
`Safety Report
`
`52,003 Certican® 05/0512005 Dr. L. Miller: Cardiac tamponade, anastomotic leak,
`unresponsive to verbal stimuli, fall, cardiac arrest,
`accelerated idioventricular rhythm; Follow-up#2.
`
`356 A2403
`
`Safety Report
`
`52,003 Certican® 05/0512005 TELECON with FDA regarding Advisory Committee meeting
`date and the teleconference to be scheduled for the new
`heart study A2310 regarding modeling and simulations.
`
`Memo of Record (telephone
`report)
`
`52,003 Certican® 05/04/2005 Richard Stone, MD: Interstitial lung disease, pneumonitis, 355 2207
`nausea, dyspnoea, hypoxia, pleural effusion, performance
`status decreased, cough, pulmonary fibrosis,
`
`Safety Report
`
`
`
`

`
`REF PRODUC DATE
`
`DESCRIPTION
`
`52,003 Certican® 05103/2005 Dr. L. Miller: Cardiac tamponade, anastomotic leak,
`unresponsive to verbal stimuli, fall, cardiac arrest,
`accelerated idioventricular rhythm; Follow-up#1
`
`SERI PROTOCOL SUBMISSION TYPE
`
`354 2403
`
`Safety Report
`
`52,003 Certican® 04/2812005 Dr. L. Miller. Cardiac tamponade, anastomic leak,
`unresponsive to verbal stimuli, fall.
`
`353 2403
`
`Safety Report
`
`52,003 Certican® 04/2712005
`
`52,003 Certican® 04/24/2005
`
`[GREAT BRITAIN) Prof. Ian Judson: Cryptogenic
`organizing pneumonia, lung infiltration, dyspnoea, dyspnoea
`exertional.
`[GERMANY I Peter Reichardt: Neoplasm progression,
`tumour haemorrhage, haemoglobin decreased, blood
`lactate dehydrogenase increased, blood potassium
`increased, blood uric acid increased, hyperbilirubinaemia,
`blood creatinine increased; Follow-up#1.
`
`352 2101
`
`Safety Report
`
`350 2206
`
`Safety Report
`
`52,003 Certican® 04119/2005 New Investigator to Study No. CRAD001A2401: Ors. M.
`Koerner, E. Hartmann, H. Shidban, J. D. Whelchel, J.
`Leone, G. Basadonna. Study No. CRAD001A2403: Ors. D.
`Mancini, L. R. Goldberg.
`·
`
`349 A2401
`A2403
`
`New Investigator
`
`52,003 Certican® 04/1812005
`
`[ GERMANY) Peter Reichardt: Tumour lysis syndrome,
`tumour haemorrhage, haemoglobin decreased, blood
`lactate dehydrogenase increased, blood potassium
`increased, blood uric acid increased, hyperbilirubinaemia,
`blood creatinine increased.
`
`348 2206
`
`Safety Report
`
`52,003 Certican® 04/0812005 James Yao: Hypoglycaemia, feeling abnormal, confusions! 347 BUS52
`state.
`
`52,003 Certican® 04/0612005
`
`[GERMANY) Dr. Kaltenhaeuser: Septic shock, peripheral 346
`occlusive disease, vasculitis, drug level decreased, skin
`ulcer, haemoglobin decreased, C-reactive protein
`increased.
`
`52,003 Certican® 04/04/2005 TELECON with FDA regarding CIOMS VI recommendations
`and investigator notifications from transplant and oncology
`indications.
`
`52,003 Certican® 0312812005 FAX from FDA containing questions on Serial Number 339,
`341and342.
`
`Safety Report
`
`Safety Report
`
`Memo of Record (telephone
`report)
`
`52,003 Certican® 03115/2005 · [SWITZERLAND) Malabsorption, acne, drug interaction,
`drug level decreased.
`
`345
`
`Safety Report
`
`52,003 Certican® 03109/2005 New Investigator to Study No. CRAD001A2401: Ors. L.
`Goldberg, A. H. Wilkinson, R. Peddi, C. A. Shadur.
`
`344 A2401
`
`NeY' Investigator
`
`52,003 Certican® 03102/2005
`
`{ CANADA I DR. Cole: Diffuse alveolar damage,
`cryptogenic organizing pneumonia, obliterative bronchiolitis,
`lung transplant rejection, cardiac arrest, pneumonia, viral
`infection, respiratory tract infection, pulmonary oedema,
`pulmonary fibrosis, respiratory disorder, haemodynamic
`instability, dyspnoea, hypoxia, myalgia, pyrexia, productive
`cough, respiratory failure, circulatory collapse.
`
`343 A2401
`
`Safety Report
`
`52,003 Certican® 02/16/2005 Submission of replacement pages for the draft clinical
`protocol (Study CRAD001A2310) submitted February 4,
`2005 (Serial No. 339).
`
`342
`
`Clinical Information Amendr
`
`52,003 Certican® 02/07/2005 New Investigator to Study No. CRAD001A2405: Ors.
`Randall C. Starling, John M. Herre.
`
`340 2405
`
`New Investigator
`
`52,003 Certican® 02/04/2005 This submission provides a point-by-point response to the
`Division's comments dated December 3, 2004, and contains
`the revised complete protocols for review and comment.
`
`Clinical Information Amendr
`Response to FDA Request
`
`
`
`

`
`REF PRODUC DATE
`
`DESCRIPTION
`
`SERI PROTOCOL SUBMISSION TYPE
`
`52,003 Certican® 01125/2005 Letter of cross reference granting pennission to the Division 338
`of Special Pathogen and Immunologic Drug Products to
`allow representatives from other branches of the FDA to
`discuss those parts of our documents relevant for Guidant's
`Drug Eluting Stent lnvestigational Device Exemptions.
`
`52,003 Certican® 01/14/2005 This letter authorizes the FDA to refer to this IND (and NOA 337
`21-560 and 21-628) in support of an IND that will be filed by
`W. H. Tang, MD.
`
`General Correspondence
`
`General Correspondence
`
`52,003 Certican® 12/22/2004 New Investigator to Study No. CRAD001A2403: Dr. Leslie 336 A2403
`Miller, MD.
`
`New Investigator
`
`52,003 Certican® 12/14/2004 New Investigator to Study No. CRAD001AUS09: Dr. Oleh 335 US09 A2401 New Investigator
`Pankewycz, MD. Study No. CRAD001A2401: Dr. Randall
`Starling.
`
`52,003 Certican® 12/09/2004
`
`[CANADA) Dr. Cole: Diffuse alveolar damage,
`cryptogenic organizing pneumonia, obliterative bronchiolitis,
`lung transplant rejection, cardiac arrest, pneumonia, viral
`infection, respiratory tract infection, pulmonary oedema,
`pulmonary fibrosis, respiratory disorder, haemodynamic
`instability, dyspnoea, hypoxia, myalgia, pyrexia, productive
`cough; Follow-up#2.
`
`334 2401
`
`Safety Report
`
`52,003 Certican® 12/03/2004 New Investigator to Study No. CRAD001A2401: Ors. P. J. 333 2401 2403 New Investigator
`2405
`Hauptman, A. Guasch, R. M. Ferguson. Study No.
`CRAD001A2403: Dr. G. M. Felker. Study No.
`CRAD001A2405: Dr. J,. Kobashigawa.
`
`52,003 Certican® 11/0512004 New Investigator to Study No. CRAD001 US09: Ors. D.
`Cibrik, M. Hardy; Study No. CRAD001A2401: Ors. J. Butler,
`F. Wright, G. Klintmalm, K. Butt, J. A. Hill; Study No.
`CRAD001 A2403: Ors. B. Rayburn, F. W. Smart; Study No.
`CRAD001 A2405: Dr. L. Miller.
`
`332
`
`US09 A2401 Annual Report
`A2403
`A2405
`
`52,003 Certican® 11/02/2004 Dr. Meir Wetzer. MD: Cardiac failure congestive, asthma,
`dyspnoea, oedema peripheral, eyelid oedema, weight
`increased, dilatation atrial, ventricular hypertrophy;
`Follow-up#1
`
`52,003 Certican® 10/29/2004
`
`[CANADA] Dr. Cole: Lung transplant rejection, cardiac
`arrest, pneumonia, viral infection, respiratory tract infection,
`respiratory disorder, haemodynamic instability, dyspnoea,
`hypoxia, myalgia, productive cough; Follow-up#1
`
`331 2207
`
`Safety Report
`
`330 2401
`
`Safety Report
`
`52,003 Certican® 10/2612004 New Investigator to Study No. CRAD001A2401: Ors. D.
`Hricik, V. G. Valentine, H. J. Eisen, T. Pruett, R. Benza, J.
`Curtis, P. R. Rajagopalan. Study No. CRAD001A2403: Dr.
`A. J. Teeter.
`
`329 A2401
`A2403
`
`New Investigator
`
`52,003 Certican® 10119/2004
`
`[SPAIN] Dr. Tabemero: Malignant neoplasm progression, 328 C2107
`stomatitis, drug ineffective, enterocolitis, abdominal pain,
`anorexia, vomiting, constipation, skin lesion, metastases to
`peritoneum, perfonnance status decreased, respiratory
`disorder, hypoalbumlnaemia, generalised oedema;
`·
`Follow-up#1.
`
`Safety Report
`
`52,003 Certican® 10/1512004
`
`[CANADA) Dr. Cole: Lung transplant rejection, cardiac
`arrest, pneumonia, respiratory tract infection, viral Infection,
`respiratory disorder, haemodynamic instability, dyspnoea,
`hypoxia, myalgia, pyrexia, productive cough.
`
`327 2401
`
`Safety Report
`
`52,003 Certican® 10/12/2004 Dr. Meir Wetzler. MD: Cardiac failure congestive,
`dyspnoea;oedema peripheral, eyelid oedema, weight
`increased, dilatation atrial, ventricular hypertrophy.
`
`326 2207
`
`Safety Report
`
`
`
`

`
`REF
`
`PRODUC DATE
`
`DESCRIPTION
`
`52,003 Certican® 10/0112004 New Investigator to Study No. CRAD001A2401: Ors. B.
`Kahan, J. E. Loyd, A. Frost, D. J. Conti, J. M. Hare. Study
`No. CRAD001 US09: Ors. M. T. Sellers, M. Cooper, S.
`Bunnapradist, V. R. Peddi, E. Hartmann, D. Norman.
`
`SERI PROTOCOL SUBMISSION TYPE
`
`325 A2401 US09 New Investigator
`
`52,003 Certican® 09/27/2004 Dr. Francis Giles: Leucocytoclastic vasculitis,
`hyperglycaemia, oedema peripheral, calcinosis 0deep vein
`thrombosis, pain, erythema, rash, eschar.
`
`324 2406
`
`Safety Report
`
`52,003 Certican® 0912412004 New Investigator to Study No. US09; Ors. S. Mulgonkar, M. 323 US09 2403 New Investigator
`2405
`I. Lorber, E. Elkhammas, R. B. Love, D. G. Wombolt; Study
`No.2403; Dr. H.J. Eisen; Study No. 2405; Dr. S. F. Davis.
`
`52,003 Certican® 0912312004
`
`[ SPAIN ] Dr. Tabemero: Enterocolitis, stomatitis,
`abdominal pain, anorexia, vomiting, constipation.
`
`322 C2107
`
`Safety Report
`
`52,003 Certican® 09120/2004 New Investigator to Study No. CRAD001A2401: Ors. S.
`Mulgonkar, M. I. Lorber, E. Elkhammas, R. B. Love, D. G.
`Wombolt: Study No. CRAD001 US09: Ors. J. Ortiz, S.
`Greenstein, M. I. Abecassis, G. Francos, R. Stephan.
`
`321 A2401 US09 New Investigator
`
`52,003 Certican® 09108/2004 Dr. Judith Wolf: Hypergl)'caemia.
`
`320 2409
`
`Safety Report
`
`52,003 Certican® 09/0312004 New protocol to Study No. CRAD001 A2403 entitled, "A
`six-Month, multicenter, randomized, Open-label Study of the
`Safety, Tolerability and Efficacy of two Neoral doses in
`addition to Certican and Steroids in de novo Heart
`Transplant Recipients". Investigator. Howard Eisen, MD.
`
`52,003 Certican® 08/27/2004 Vincent Valentine. MD: Renal failure acute, renal
`insufficiency, thrombocytopenia, lung transplant rejection,
`hyperglycaemia, blood creatinine increased, blood urea
`increased, fatigue, malaise, graft loss: Follow-up#1
`
`52,003 Certican® 08/20/2004 New protocol to Study No. CRAD001 A2405 entitled, "A
`Six-Month, Multicenter, Open-Label, single arm, pilot study
`of the renal safety of Everolimus in addition to Neoral in
`cardiac transplant recipients with established Allograft
`Vasculopathy". Also, Amendment 1 to Protocol CRAD001
`A2405. New Investigator: Howard Eisen, MD. And
`Information Amendment: New Concept design for De Novo
`Heart Study.
`
`52,003 Certican® 08118/2004 Vincent Valentine. MD; Lung transplant rejection, renal
`failure acute, renal insufficiency, thrombocytopenia,
`hyperglycaemia, fatigue, malaise, graft loss, blood
`creatinine increased, blood urea increased.
`
`319 A2403
`
`New Protocol
`
`318 B152
`
`Safety Report
`
`317 A2405
`
`New Protocol
`
`316 B152E1
`
`Safety Report
`
`52,003 Certican® 0811212004
`
`[SWITZERLAND ] Prof. W. Kiowski: Pyrexia, C-reactive
`protein increased, red blood cell sedimentation rate
`increased; Follow-up#2
`
`315 B253
`
`Safety Report
`
`52,003 Certican® 0710812004 Dr. George Demetri: Ascites, disease progression, drug
`interaction, dyspnoea; Fo11ow-up#2
`
`314 2206
`
`Safety Report
`
`52,003 Certican® 0710212004 Dr. George Demetri: Ascites, disease progression,
`dyspnoea; Follow-up#1
`
`313 2206
`
`Safety Report
`
`52,003 Certican® 06128/2004 Dr. George Demetri: Dyspnoea, ascites, disease
`progression, drug ineffective.
`
`312 2206
`
`Safety Report
`
`52,003 Certican® 0611612004
`
`[BELGIUM ] Dr. Van Oosterom: Gastritis haemorrhagic,
`right ventricular failure, pulmonary hypertension, anaemia,
`blood in stool, general physical health deterioration:
`Follow-up#2
`
`311 2206
`
`Safety Report
`
`
`
`

`
`REF PRODUC DATE
`
`DESCRIPTION
`
`SERI PROTOCOL SUBMISSION TYPE
`
`52,003 Certican® 06/14/2004
`
`[ BELGIU.M] Dr. Van Oosterom: Gastritis haemorrhagic,
`right ventricular failure, pulmonary hypertension, anaemia,
`blood in stool, general physical health deterioration;
`Follow-up#1
`
`310 · 2206
`
`Safety Report
`
`52,003 Certican® 06/10/2004 This Annual Report covers the period November 15, 2002
`through November 14, 2003. lndudes clinical/preclinical
`information and Foreign marketing developments.
`
`52,003 Certican® 06/10/2004
`
`[BELGIUM J Dr. Van Oosterom: Gastritis haemorrhagic,
`right ventricular failure, pulmonary hypertension, anaemia,
`blood in stool, general physical health deterioration.
`
`309
`
`Annual Report
`
`308 2206
`
`Safety Report
`
`52,003 Certican® 06/0312004 Howard A. Burris, Ill, MD; Epistaxis, platelet count
`decreased, bleeding time prolonged; Follow-up#1
`
`307 2101
`
`Safety Report
`
`52,003 Certican® 05124/2004
`
`[SWITZERLAND] Prof. W. Kiowski: Pyrexia, C-reactive
`protein increased, red blood cell sedimentation rate
`increased; Follow-up#1
`
`306 8253
`
`Safety Report
`
`52,003 Certican® 05/03/2004 Howard A. Burris, Ill, MD: Epistaxis, platelet count
`decreased, bleeding time prolonged.
`
`305 2101
`
`Safety Report
`
`52,003 Certican® 04/0112004 FAX from FDA containing comments from the reviewing
`medical officer, statistician and clinical pharmacologist on
`the February 27, 2004 protocol for Study A2411.
`
`52,003 Certican® 04/06/2004
`
`(BELGIUM ] Dr. Van Oosterom: Gastritis haemorrhageic,
`thrombocytopenia, anaemia, nausea, vomiting, melaena.
`
`304 2206
`
`Safety Report
`
`52,003 Certican® 03117/2004 Amendment No.1 and Amendmen No. 2 to Study No.
`RAD001 A2410.
`
`303 A2410
`
`Change In Protocol
`
`52,003 Certican® 03/17/2004 Amendment No. 1 and Amendment No. 2 to Study No.
`RAD001 A2409.
`
`302 A2409
`
`Change In Protocol
`
`52,003 Certican® 03/17/2004 Amendment No.1 and Amendment No. 2 to Study No.
`RAD001 A2408.
`
`301 A2408
`
`Change In Protocol
`
`52,003 Certican® 03/15/2004 New protocol to Study No. A2409 entitled, "Open-label,
`two-period, single-sequence, crossover study to evaluate
`the influence of ketoconazole on the pharmacokinetics of
`everolimus in healthy subjects. Investigator: Dr. Magdy
`Shenouda, MD.
`
`52,003 Certican® 03/12/2004 New protocol to Study No. A2410 entitled, "A open-label,
`two-period, single-sequence, crossover study to evaluate
`the influence of verapamil on the pharmacokinetics of
`everolimus in healthy subjects. New investigator: Mark.J.
`Allison, MD.
`
`52,003 Certican® 03/11/2004 New protocol to Study No. A 2408 entitled, "Open-label,
`two-period, single-sequence, crossover study to evaluate
`the influence of erythromycin on the pharmacokinetics of
`everolimus in healthy subjects. Investigator: Dr. Magdy
`Shenouda, MD.
`
`52,003 Certican\li) 03110/2004 FAX from FDA containing comments on the drug-drug
`interaction protocols submitted February 18, 2004, Serial
`No. 294)
`
`300 A2409
`
`New Investigator
`New Protocol
`
`299 A2410
`
`New Investigator
`New Protocol
`
`298 A2408
`
`New Investigator
`New Protocol
`
`52,003 Certican® 03105/2004 New Investigator to Study No. A 2401: Dr. Jeffrey Punch,
`MD.
`
`297 A2401
`
`New Investigator
`
`
`
`

`
`REF PRODUC DATE
`
`DESCRIPTION
`
`52,003 Certican® 02127/2004
`
`52,003 Certican® 02127/2004
`
`[ FRANCE ] Alexandre Karras; Histiocytosis
`haematophagic, human herpesvirus 6 infection, graft loss,
`lymphadenopathy, neurological symptom, gastrointestinal
`disorder, weight decreased, pyrexia, anaemia, haemoglobin
`decreased, white blood cell count decreased, platelet count
`decreased, liver function test abnonnal, blood lactate
`dehydrogenase increased, blood triglycerides increased,
`serum ferritin increased, hyponatraemia, nephrectomy.
`
`In response to the approvable letter for NOA 21-628 and
`subsequent interactions with the Division, this submission
`contains a revised study summary and protocol for a de
`novo heart transplantation study for review and comment
`prior to initiation.
`
`SERI PROTOCOL SUBMISSION TYPE
`
`296
`
`Safety Report
`
`295 A2411
`
`Clinical lnfonnation Amendr
`Response !o FDA Request
`
`52,003 Certican® 02/18/2004
`
`In response to a recommendation from the Division at the
`January 6, 2004 teleconference for drug interaction studies,
`this submission contains final protocols for each drug
`interaction study and a request for timely review comments.
`
`294
`
`52,003 Certican® 02/13/2004 FAX from FDA containing comments on the protocol
`synopses for three drug-drug interaction studies submitted
`February 6, 2004.
`
`52,003 Certican® 02/03/2004
`
`In response to a recommendation from the Division at the
`January 6, 2004 teleconference for drug Interaction studies,
`this submission contains a stl.idy summary and assessment
`schedule for each drug interaction study
`
`293
`
`Response to FDA Request
`
`52,003 Certican® 12/08/2003 This letter authorizes FDA to refer to this IND in support of 291
`an IND that will be filed by B. Kahan, MD.
`
`General Correspondence
`
`52,003 Certican® 11/0312003 New protocol: Study No. CRAD001AUS09 entitled, "A
`prospective, multicenter, open label, randomized study of
`the safety, tolerability and efficacy of Certican (RAD001)
`with Simulect, corticosteroids and lower levels versus higher
`levels of tacrolimus in de novo renal transplant recipients.
`
`290 US09
`
`New Protocol
`
`52,003 Certican® 10/01/2003
`
`52,003 Certican® 09/26/2003
`
`52,003 Certican® 09115/2003
`
`[SWEDEN] Gunnar Martensson: Respiratory failure,
`cardiac failure NOS, pneumonitis NOS, acute respiratory
`distress syndrome, coagulopathy, bronchial obstruction,
`asthma nos, hypoxia, lung infiltration NOS, alveolitis NOS,
`pulmonary haemorrhage, pulmonary oedema NOS,
`hypoperfusion, atelectasis, lung consolidation, dyspnoea,
`eosinophilia; Follow-up#4
`
`[SWEDEN J Gunnar Martensson: Respiratory failure,
`cardiac failure NOS, pneumonitis NOS, lung disorder NOS,
`coagulopathy, bronchial obstruction, asthma NOS, hypoxia,
`lung infiltration NOS.,alveolitis NOS, pulmonary
`haemorrhage, lung consolidation, dyspnoea, eosinophilia;
`Follow-up#3.
`
`(AUSTRALIA] Dr. Scott Campbell; Optic neuropathy
`NOS, nuclear magnetic resonance imaging brain abnonnal,
`vision blurred, visual acuity reduced; Follow-up#3
`
`289 8159
`
`Safety Report
`
`288 B159
`
`Safety Report
`
`287 A2307
`
`Safety Report
`
`52,003 Certican® 09112/2003 Minutes of the September11and12, 2003, meeting to
`discuss the Pediatric Written RequeSt.
`
`FDA/Novartis Meeting Mimr
`
`52,003 Certican® 0911112003 TELECON with FDA to discuss Novartis' Request for a Type
`A Meeting on the Written Request and data exclusivity.
`
`Memo of Record (telephone.
`report)
`
`52,003 Certican® 09/05/2003 FDA LETTER responding to the request for a meeting to
`discuss the pediatric Written Request.
`
`52,003 Certican® 08121/2003 Request a Type A meeting to discuss the Written Request 286
`prior to the NOA action date of October 20, 2203 (NDAs
`21-560 and 21-628).
`
`Request for FDA Meeting
`
`
`
`

`
`REF PRODUC DATE
`
`DESCRIPTION
`
`SERI PROTOCOL SUBMISSION TYPE
`
`52,003 Certican® 0810712003 TELECON with FDA regarding 24 month statistical analysis
`plan for Study No. 8159 (Submitted July 9, 2003, Serial No.
`285)
`
`52,003 Certican® 08101/2003 TELECON with FDA to discuss the statistical proposals
`found acceptable for Study 8159 24-month data analysis.
`
`52,003 Certican® 07/1012003
`
`In reference to the Pre-NOA meeting held on May 1, 2003, 285 8159
`this amendment to Study B 159 provides for a detailed
`statistical methodology for the 24-month data analysis.
`
`52,003 Certican® 05/27/2003 Submission of slides presented at pre-NOA meeting held on 284
`May 1, 2003, to discuss·the use of Certican in lung
`transplantation.
`
`52,003 Certican® 0510512003 FAX from FDA containing attendence sheets for May 1,
`2003 pre-NOA meeting.
`
`52,003 Certican® 05101/2003 FDA minutes of the May 1, 2003 pre-NOA/Type B meeting.
`The purpose of the meeting was to obtain feedback from the
`Agency concerning the proposad NOA in lung
`transplantation.
`
`52,003 Certican® 04/29/2003 FAX from FDA containing comments concerning pre-NOA
`background package (Serial No. 281)
`
`52,003 Certican® 04/2512003 FAX from FDA containing comments concerning pre-NOA
`background package (Serial No. 281)
`
`52,003 Certican® 04/0712003 FDA LETTER containing details of the Type B meeting
`scheduled for May 1, 2003, requested March 21, 2003.
`
`Memo of Record (telephone
`report)
`
`Memo of Record (telephone
`report)
`
`Change In Protocol
`
`General Correspondence
`
`FDA/Novartis Meeting Mims
`
`52,003 Certican® 0410312003 This Annual Report covers the period November 15, 2001
`through November 14, 2002. Includes clinical and
`preclinical study/safety information.
`
`283
`
`Annual Report
`
`52,003 Certican® 04/01/2003 Submission of additional desk copies of the Briefing Book
`dated March 21, 2003.
`
`282
`
`52,003 Certican® 03121/2003 This Briefing Book is being submitted In preparation for a
`pre-NOA (Type B) meeting. scheduled May 1, 2003, to
`discuss submission proposals to support the use of Certican
`in lung transplantation. This Briefing Book replaces
`submission dated March 4, 2003 (Serial No. 279)
`
`281
`
`Response to FDA Request
`
`Briefing Book
`
`52,003 Certican® 03119/2003
`
`[SWEDEN J Gunnar Martensson; Respiratory failure,
`cardiac failure NOS, pneumonitis NOS, bronchial
`obstruction, asthma NOS, hypoxia, lung infiltration NOS,
`alveolitis NOS, pulmonary haemorrhage, lung consolidation,
`dyspnoea NOS, eosinophilia; Follow-up#2
`
`280 B159
`
`Safety Report
`
`52,003 Certican® 0310412003 Request for pre-NOA meeting (Type B) to discuss
`submission proposals in support of an NOA for the use of
`Certican in lung transplantation.
`
`279
`
`52,003 Certican® 0211912003
`
`52,003 Certican® 01/0312003
`
`[SWEDEN] Gunnar Martensson; Respiratory failure,
`cardiac failure NOS, pneumonitis NOS, bronchial
`obstruction, asthma NOS, hypoxia, lung infiltration NOS,
`alveolitis NOS, lung consolidation, dyspnoea NOS,
`eosinophilla; Follow-up#1
`[AUSTRALIA l Dr. Scott Campbell; Optic neuropathy
`NOS, nuclear magnetic resonance imaging .brain abnormal,
`vision blurred, visual acuity reduced; FoHow-up#2
`
`278 8159
`
`Safety Report
`
`277 2307
`
`Safety Report
`
`52,003 Certican® 1212412002
`
`[AUSTRALIA] Dr. Scott Cambell; Optic neuropathy NOS, 276 2307
`nuclear magnetic resonance imaging brain abnormal, vision
`blurred, visual acuity reduces; Follow-up#1
`
`Safety Report
`
`
`
`

`
`REF PRODUC DATE
`
`DESCRIPTION
`
`SERI PROTOCOL SUBMISSION TYPE
`
`52,003 .Certican® 11119/2002 TELECON with FDA on November 18 and 19, 2002 to
`discuss tradename potential for similarity between Certican
`and Foradil Certihaler.
`
`52,003 Certlcan® 10/29/2002 TELECON with FDA regarding the SAS data transfer.
`
`52,003 Certican® 10/2512002 Minutes of the October 25, 2003 meeting to discuss plans
`for submitting Iha statistical datasets for the upcoming
`NDAs.
`
`52,003 Certican® 10/21/2002 FDA LETTER asking Novartis to detennine if the new
`protocol submitted August 6, 2002, Serial No. 268, meets
`the requirements for listing in the Clinical Trials Data Bank.
`
`Memo of Record (telephone
`report)
`
`Memo of Record (telephone
`report)
`
`FDA/Novartis Meeting Minu·
`
`52,003 Certican® 10/17/2002
`
`[Sweden] Gunnar Martensson; Pneumonitis NOS, bronchial 274 B159
`obstruction, asthma NOS, Hypoxia, alveolitis NOS,
`respiratory failure, lungconsolidation, dyspnoea NOS,
`eosinophilia
`
`Safety Report
`
`52,003 Certican® 1011512002
`
`[France] Prof Bourbigot; Protocol No. CRAD001 A2307;
`renal impainnent NOS, hepatitis acute, concomitant disease
`progression, blood creatinine increased,
`gamma-glutamyltransferase increased, aspartate
`aminotransferase increased, alanine aminotransferase
`increased; follow-up# 2
`
`273 A2307
`
`Safety Report
`
`52,003 Certican® 09/20/2002
`
`[Australia) Dr Scott Campbell; Optic neuropathy NOS, vision 272 A2307
`blurred, visual acuity reduced
`
`Safety Report
`
`52,003 Certican® 09/0512002 TELECON from FDA assigning NOA Numbers and User
`Fee ID#.
`
`52,003 Certlcan® 09/04/2002 TELECON with FDA to discuss the submission of a new
`Oncology IND for RAD.
`
`52,003 Certican® 09/04/2002 A telecon is being requested to discuss a proposal for the
`transfer of SAS datasets and programs for Division review.
`
`271
`
`Memo of Record (telephone
`report)
`
`Memo of Record (telephone
`report)
`
`General Correspondence
`
`52,003 Certican® 0811512002 This submission provides a copy of the communication
`received from the Data Safety Monitoring Board (DSMB)
`dated July 23, 2002 and the Novartis written notification to
`Study B253 investigators, dated July 26, 2002.
`
`270
`
`Clinical Information Arnendr
`
`52,003 Certican® 0810812002 n reference to a telephone conversation on August 5, 2002, 269
`regarding a GCP audit, this correspondence provides
`written notification to the file with a copy of the letter
`submitted on August 6, 2002, to the Division of Scientific
`Investigations.
`
`General Correspondence
`
`268 US08
`
`New Protocol
`
`52,003 Certican® 0810612002 New protocol: Study No. US08 entitled, "Single center,
`prospective, single-ann, open-label trial of rapid steroid
`withdrawal in combination with Certican (RAD), Simulect,
`and Neoral for the prevention of acute rejection in de novo
`renal transplant recipients". Investigator: R. M. Ferguson,
`MD
`
`52,003 Certican® 0810512002 TELECON with FDA regarding the UCLA GCP audit
`findings and Novartis' intent to infonn OSI.
`
`52,003 Certican® 0810512002 This letter authorizes FDA to refer to this IND in support of 267
`an IND filed by B: J. Hering, MD (BB-IND 8919).
`
`Memo of Record (telephone
`report)
`
`· General Correspondence
`
`52,003 Certican® 07/17/2002 New investigator to Study No. 2307: M. L Lorber, MD
`
`266
`
`2307
`
`New Investigator
`
`52,003 Certican® 0711212002
`
`In reference to the pre-NOA meeting held on March 25,
`2002, and to the FDA Meeting Minutes, this correspondence
`requests clarification on several issues raised in the minutes
`and contains revision to those minutes.
`
`265
`
`
`
`

`
`REF PRODUC DATE
`
`DESCRIPTION
`
`52,003 Certican® 07/11/2002
`
`[France] Prof Bourbigot; Protocol No. CRAD001 A2307;
`renal impainnent NOS, hepatitis acute, conccimitent disease
`progression, blood creatinine increased,
`gamma-glutamyltransferase increased, aspartate
`aminotransferase increased, alanine aminotransferase
`increased; follow-up
`
`52,003 Certican® 07/0212002 FDA LETTER referencing the "Best Phannaceuticals for
`Children Act:' (BPCA) and serving as notification that the
`Written Request, originally issued on April 25, 2000, is
`considered to be reissued as of the date of this letter.
`
`52,003 Certican® 06103/2002 Barry Donald Kahan, MD; Protocol No. FTY A2202;
`anassarca, disease progression NOS, oedema NOS,
`dyspnoea exertional, weight increased, blood creatinine
`increased
`
`SERI PROTOCOL SUBMISSION TYPE
`
`264 A2307
`
`Safety Report
`
`261 A2202
`
`Safety Report
`
`52,003 Certican® 05/29/2002 New investigators: Study No. 2306: Ors. J. Magee, P.
`Morissey; Study No. 2307: Ors. D. Nonnan, J. D. Scandling
`
`260 23062307
`
`New Investigator
`
`52,003 Certican® 05/15/2002 New investigator to Study No. 2307: F. H. Wright, MD
`
`259