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Appendix B: List of Approved Applications
FY 2008 PDUFA Performance Report Table of Contents
This appendix updates the detailed review histories of the NDAs and BLAs submitted and approved under PDUFA in FY 2008. Approvals are grouped by submission year and priority designation and listed in order of total approval time. Review histories of all other PDUFA submissions approved prior to FY 2008 can be found in the appendices of the earlier PDUFA Performance Reports that are available at http://www.fda.gov.
Terms and Coding Used in Tables
|
Action Codes: |
AE AP NA CR TA WD |
= = = = = = |
Approvable Approved Not Approvable Complete Response Tentative Approval Withdrawn |
* Tentative Approval (TA) is an action given to a product that meets all the requirements for approval; however, it may not be legally marketed in the United States until the market exclusivity and/or patent term of the listed reference drug product has expired.
◊ Expedited review and TA of a NDA by FDA for fixed dose combinations and co-packaged antiretroviral medications as part of the President’s Emergency Plan for AIDS Relief.
+ Major amendment was received within 3 months of the action due date, which extended the action goal date by 3 months.
Table 1
FY 2008 Priority NDA and BLA Approvals (by FY of receipt)
| Receipt Cohort (FY) |
Established/Proper Name |
Applicant | NME (Y/N) | Approval Time (Months) | Goal Met | |||
|---|---|---|---|---|---|---|---|---|
| Review Cycle | Cycle Time | Cycle Result | Total Time | |||||
| 2008 | DIFLUPREDNATE | Sirion Therap | Y | First | 5.9 | AP | 5.9 | Y |
| ABICAVIRE SULFATE TABLETS | Aurobindo Pharm | N | First | 5.9 | TA | 5.9 | Y◊ | |
| IOBENUANE I 123 INJECTION | GE Healthcare | Y | First | 6.0 | AP | 6.0 | Y | |
| LAMIVUDINE/ STAVUDINE TABLETS FOR ORAL SUSPENSION |
Cipla | N | First | 6.0 | TA | 6.0 | Y◊ | |
| TENOFAVIR DISOPROXYL FURMATE/ LAMIVUDINE | Matrix Labs Ltd. | N | First | 6.0 | TA | 6.0 | Y◊ | |
| TIPRANAVIR 2-PYRIDINESULFONANILIDE | Boehringer Pharms | N | First | 6.1 | AP | 6.1 | Y† | |
| 2007 | IXABEPILONE | Bristol Myers Squibb | Y | First | 6.0 | AP | 6.0 | Y |
| RALTEGRAVIR POTASSIUM | Merck And Co. Inc. | Y | First | 6.0 | AP | 6.0 | Y | |
| TMC 125 ETRAVIRINE | Tibotec | Y | First | 6.0 | AP | 6.0 | Y | |
| BENDAMUSTINE HCL | Cephalon | Y | First | 6.0 | AP | 6.0 | Y | |
| TOPOTECAN HCL | Smithkline Beecham | N | First | 6.0 | AP | 6.0 | Y | |
| TRIAMCINOLONE ACETONIDE INJECTABLE SUSP | Alcon | N | First | 6.0 | AP | 6.0 | Y | |
| SAPROPTERIN DIHYDROCHLORIDE | Biomarin Pharm | Y | First | 6.7 | AP | 6.7 | N | |
| STAVUDINE / LAMIVUDINE | Matrix Labs Inc. | N | First | 7.2 | TA | 7.2 | N◊ | |
| STAVUDINE / LAMIVUDINE / NEVIRAPINE | Strides Inc. | N | First | 6.0 | CR | 6.0 | Y | |
| Sponsor | 0.3 | -- | 6.3 | -- | ||||
| Second | 4.4 | TA | 10.7 | Y◊ | ||||
| STAVUDINE / LAMIVUDINE / NEVIRAPINE | Strides Arcolab | N | First | 9.0 | CR | 9.0 | Y+ | |
| Sponsor | 0.2 | -- | 9.2 | -- | ||||
| Second | 6.0 | TA | 15.2 | Y◊ | ||||
| 2005 | TIPRANAVIR ORAL SOLUTION | Boehringer Pharms | Y | First | 6.0 | CR | 6.0 | Y |
| Sponsor | 30.0 | -- | 36.0 | -- | ||||
| Second | 6.1 | AP | 42.1 | Y† | ||||
| TETRABENAZINE | Biovail Americas | Y | First | 5.9 | CR | 5.9 | Y | |
| Sponsor | 12.4 | -- | 18.3 | -- | ||||
| Second | 8.8 | CR | 27.1 | Y+ | ||||
| Sponsor | 0.8 | -- | 27.9 | -- | ||||
| Third | 2.0 | CR | 29.9 | Y | ||||
| Sponsor | 3.0 | -- | 32.9 | -- | ||||
| Fourth | 2.0 | AP | 34.9 | Y | ||||
† An exception was granted to extend the review time goal date by two business days due to an unscheduled emergency closure of the FDA facility.
Table 2
FY 2008 Standard NDA and BLA Approvals (by FY of receipt)
| Receipt Cohort (FY) |
Established/Proper Name |
Applicant | NME (Y/N) | Approval Time (Months) | Goal Met | |||
|---|---|---|---|---|---|---|---|---|
| Review Cycle | Cycle Time | Cycle Result | Total Time | |||||
| 2008 | REPAGLINIDE METFORMIN | Novo Nordisk Inc. | N | First | 1.0 | AP | 1.0 | Y |
| NICARDINE | Teva Parenteral | N | First | 9.8 | AP | 9.8 | Y | |
| PALONOSETRAN HCL | Helsinn Hlthcare | N | First | 10.0 | AP | 10.0 | Y | |
| LEVETIRACETAM | Ucb Inc. | N | First | 10.0 | AP | 10.0 | Y | |
| 2007 | MORPHINE SULFATE IMMEDIATE RELEASE TABS | Roxane | N | First | 9.3 | AP | 9.3 | Y |
| FIBRIN SEALANT (HUMAN) | Baxter Healthcare Corporation | Y | First | 9.6 | AP | 9.6 | Y | |
| ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ ALBUMIN FREE | Wyeth Pharmaceuticals Inc. | Y | First | 9.9 | AP | 9.9 | Y | |
| DICLOFENAC SODIUM TOPICAL GEL 1% | Novartis cons | N | First | 9.9 | AP | 9.9 | Y | |
| ROTAVIRUS VACCINE, LIVE, ORAL | Glaxosmithkline Biologicals | Y | First | 10.0 | AP | 10.0 | Y | |
| TRIAMCINOLONE | Allergan | N | First | 10.0 | AP | 10.0 | Y | |
| DORIPENEM | Johnson and Johnson | Y | First | 10.0 | AP | 10.0 | Y | |
| SEVELAMER CARBONATE | Genzyme | N | First | 10.0 | AP | 10.0 | Y+ | |
| STERILE INTRAOCULAR IRRIGATING SOLUTION | Alcon | N | First | 10.0 | AP | 10.0 | Y | |
| NIACIN/SIMVASTATIN | Abbott Labs | N | First | 10.0 | AP | 10.0 | Y | |
| ALISKIREN HYDROCHLOROTHIAZIDE | Novartis Pharms | N | First | 10.0 | AP | 10.0 | Y | |
| AVOBENZENE/ECAMSULE/ OCTOCRYLENE/ TITANIUM |
Loreal USA Prods | N | First | 10.0 | AP | 10.0 | Y | |
| EPOPROSTENOL SODIUM | Generamedix | N | First | 10.0 | AP | 10.0 | Y | |
| MORPHINE SULPHATE ORAL SOLUTION | Roxane | N | First | 10.0 | AP | 10.0 | Y | |
| CETIRIZINE HCL | McNeil Consumer | N | First | 10.0 | AP | 10.0 | Y | |
| LEVOCETIRZINE DIHYDROCHLORIDE | Ucb Inc. | N | First | 10.0 | AP | 10.0 | Y | |
| AMOXICILLIN / APC-111 | Middlebrook Pharms | N | First | 10.0 | AP | 10.0 | Y | |
| CALCIPOTRIENE HYDRATE AND BETAMETHASONE | Leo Pharm Prods | N | First | 10.4 | TA | 10.4 | N | |
| REGADENOSON | Astellas | Y | First | 10.9 | AP | 10.9 | N | |
| GADOXETATE DISODIUM | Bayer Healthcare | Y | First | 12.1 | AP | 12.1 | N | |
| VALPROIC ACID DELAYED RELEASE CAPSULES | Banner Pharmacaps | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 0.3 | -- | 10.3 | -- | ||||
| Second | 1.8 | TA | 12.1 | Y | ||||
| METHYLNALTREXONE BROMIDE SUBCUTANEOUS INJECTION | Progenics | Y | First | 12.9 | AP | 12.9 | Y+ | |
| THROMBIN TOPIC (RECOMBINANT) | ZymoGenetics, Inc. | Y | First | 13.0 | AP | 13.0 | Y+ | |
| CLEVIDIPINE IV EMULSION | Meds Co. | Y | First | 13.0 | AP | 13.0 | Y+ | |
| PHENTOLAMINE MESYLATE | Novalar | N | First | 13.0 | AP | 13.0 | Y+ | |
| DOCETAXEL INJECTION | Hospira inc | N | First | 13.0 | TA | 13.0 | Y+ | |
| GRAINSETRON TRANSDERMAL SYSTEM / GRANISETR | Strakan | N | First | 14.4 | AP | 14.4 | N | |
| DIPHTHERIA AND TETANUS TOXOIDS, ACELLULAR PERTUSSIS VACCINE ADSORBED AND POLIOVIRUS VACCINE INACTIVATED COMBINED | Glaxosmithkline Biologicals | Y | First | 9.9 | CR | 9.9 | Y | |
| Sponsor | 3.0 | -- | 12.9 | -- | ||||
| Second | 1.6 | AP | 14.5 | Y | ||||
| OMEPRAZOLE MAGNESIUM | Astrazeneca | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 2.9 | -- | 12.9 | -- | ||||
| Second | 2.2 | AP | 15.1 | N | ||||
| FLUORESCEIN INJECTION | Akorn | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 1.8 | -- | 11.8 | -- | ||||
| Second | 4.3 | AP | 16.1 | Y | ||||
| ROPINIROLE HYDROCLORIDE | Smithkline Beecham | N | First | 9.9 | CR | 9.9 | Y | |
| Sponsor | 0.4 | -- | 10.3 | -- | ||||
| Second | 5.9 | AP | 16.2 | Y | ||||
| CEFEPIME INJECTION | Baxter | N | First | 9.7 | CR | 9.7 | Y | |
| Sponsor | 1.6 | -- | 11.3 | -- | ||||
| Second | 6.0 | AP | 17.3 | Y | ||||
| VENLAFAXINE HCL | Osmotica Pharm | N | First | 9.8 | CR | 9.8 | Y | |
| Sponsor | 2.3 | -- | 12.1 | -- | ||||
| Second | 2.5 | CR | 14.6 | Y | ||||
| Sponsor | 0.8 | -- | 15.4 | -- | ||||
| Third | 2.0 | AP | 17.4 | Y | ||||
| 2006 | NILOTINIB | Novartis Pharms | Y | First | 13.0 | AP | 13.0 | Y+ |
| ESOMEPRAZOLE MAGNESIUM | Astrazeneca | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 5.1 | -- | 15.1 | -- | ||||
| Second | 2.1 | AP | 17.2 | Y | ||||
| PREDNISOLONEACETATE ORAL SUSPENSION | Taro Pharms (US) | N | First | 13.0 | CR | 13.0 | Y+ | |
| Sponsor | 2.3 | -- | 15.3 | -- | ||||
| Second | 1.9 | AP | 17.2 | Y | ||||
| PANTOPRAZOLE SODIUM | Wyeth Pharms Inc | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 4.7 | -- | 14.7 | -- | ||||
| Second | 3.5 | AP | 18.2 | N | ||||
| BUPROPION / HYDROBROMIDE | Biovail Labs Intl. | N | First | 9.7 | CR | 9.7 | Y | |
| Sponsor | 3.2 | -- | 12.9 | -- | ||||
| Second | 6.0 | AP | 18.9 | Y | ||||
| FOSAPREPITANT DIMEGLUMINE | Merck and Co. Inc. | N | First | 13.0 | CR | 13.0 | Y+ | |
| Sponsor | 2.8 | -- | 15.8 | -- | ||||
| Second | 6.0 | AP | 21.8 | Y | ||||
| OMEPRAZOLE DELAYED RELEASE TABLETS 20MG | Dexcel Pharma | N | First | 9.9 | CR | 9.9 | Y | |
| Sponsor | 10.1 | -- | 20.0 | -- | ||||
| Second | 2.0 | AP | 22.0 | Y | ||||
| FLUVOXAMINE MALEATE | Jazz | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 3.8 | -- | 13.8 | -- | ||||
| Second | 6.0 | CR | 19.8 | Y | ||||
| Sponsor | 0.4 | -- | 20.2 | -- | ||||
| Third | 2.0 | AP | 22.2 | Y | ||||
| 10 % METHYL SALICYLATE & 3% MENTHOL | Hisamitsu Pharm | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 7.8 | -- | 17.8 | -- | ||||
| Second | 6.0 | AP | 23.8 | Y | ||||
| COSYNTROPIN INJECTION | Sandoz | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 8.5 | -- | 18.5 | -- | ||||
| Second | 6.0 | AP | 24.5 | Y | ||||
| DESVENLAFAXINE EXTENDED-RELEASE TABLETS | Wyeth Pharms Inc. | Y | First | 13.0 | CR | 13.0 | Y+ | |
| Sponsor | 7.3 | -- | 20.3 | -- | ||||
| Second | 6.0 | AP | 26.3 | Y | ||||
| SOMATROPIN RECOMBINANT HUMAN GROWTH HORM | Cangene | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 4.6 | -- | 14.6 | -- | ||||
| Second | 12.0 | AP | 26.6 | N | ||||
| LORATADINE 10MG | Schering plough | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 11.3 | -- | 21.3 | -- | ||||
| Second | 5.9 | AP | 27.2 | Y | ||||
| 2005 | SIMVASTATIN 10/20/40/80MG TABLETS | Synthon Pharms | N | First | 9.9 | CR | 9.9 | Y |
| Sponsor | 10.8 | -- | 20.7 | -- | ||||
| Second | 5.8 | AP | 26.5 | Y | ||||
| SUMATRITAM/ NAPROXEN | Glaxosmithkline | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 7.9 | -- | 17.9 | -- | ||||
| Second | 6.0 | CR | 23.9 | Y | ||||
| Sponsor | 2.5 | -- | 26.4 | -- | ||||
| Third | 6.0 | AP | 32.4 | Y | ||||
| HAEMOPHILIS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) RECONSTITUTED WITH DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE ADSORBED COMBINED WITH POLIOVIRUS VACCINE INACTIVATED | Sanofi Pasteur Limited | Y | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 3.4 | -- | 13.4 | -- | ||||
| Second | 7.5 | CR | 20.9 | Y+ | ||||
| Sponsor | 0.4 | -- | 21.3 | -- | ||||
| Third | 1.2 | CR | 22.5 | Y | ||||
| Sponsor | 6.4 | -- | 28.9 | -- | ||||
| Fourth | 6.0 | AP | 34.9 | Y | ||||
| DESMOPRESSIN ACETATE TABLETS | Ferring Pharms | N | First | 9.7 | CR | 9.7 | Y | |
| Sponsor | 21.2 | -- | 30.9 | -- | ||||
| Second | 7.4 | AP | 38.3 | N | ||||
| BIPHASIC INSULIN ASPART 50/50 | Novo Nordisk Inc. | N | First | 6.0 | CR | 6.0 | Y | |
| Sponsor | 16.0 | -- | 22.0 | -- | ||||
| Second | 2.0 | AP | 24.0 | Y | ||||
| MESALAMINE | Proctor and Gamble | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 25.8 | -- | 35.8 | -- | ||||
| Second | 7.3 | AP | 43.1 | N | ||||
| 2004 | OLOPATADINE HCL 0.6% | Alcon | N | First | 10.0 | CR | 10.0 | Y |
| Sponsor | 23.1 | -- | 33.1 | -- | ||||
| Second | 6.7 | AP | 39.8 | N | ||||
| NEBIVOLOL TABLETS 1.25/2.5/5/10/20MG | Forest Labs | Y | First | 13.1 | CR | 13.1 | Y | |
| Sponsor | 24.0 | -- | 37.1 | -- | ||||
| Second | 6.0 | CR | 43.1 | Y | ||||
| Sponsor | 0.2 | -- | 43.3 | -- | ||||
| Third | 0.4 | AP | 43.7 | Y | ||||
| ALVIMOPAN | Adolor | Y | First | 12.9 | CR | 12.9 | Y+ | |
| Sponsor | 9.7 | -- | 22.6 | -- | ||||
| Second | 6.9 | CR | 29.5 | Y+ | ||||
| Sponsor | 9.3 | -- | 38.8 | -- | ||||
| Third | 9.4 | AP | 48.2 | N | ||||
| CICLESONIDE | Nycomed US | N | First | 10.0 | CR | 10.0 | Y | |
| Sponsor | 32.7 | -- | 42.7 | -- | ||||
| Second | 6.0 | AP | 48.7 | Y | ||||
| 2002 | FLUVOXAMINE MALEATE TABS 25/50/100 MG | Jazz | N | First | 19.4 | CR | 19.4 | Y‡ |
| Sponsor | 27.3 | -- | 46.7 | -- | ||||
| Second | 6.0 | CR | 52.7 | Y | ||||
| Sponsor | 7.2 | -- | 59.9 | -- | ||||
| Third | 6.0 | AP | 65.9 | Y | ||||
| 2001 | BRIMONIDINE TARTRATE 0.2%/ TIMOLOL 0.5% | Allergan | N | First | 8.6 | CR | 8.6 | Y |
| Sponsor | 27.4 | -- | 36.0 | -- | ||||
| Second | 6.0 | CR | 42.0 | Y | ||||
| Sponsor | 15.6 | -- | 57.6 | -- | ||||
| Third | 5.7 | CR | 63.3 | Y | ||||
| Sponsor | 4.5 | -- | 67.8 | -- | ||||
| Fourth | 6.0 | AP | 73.8 | Y | ||||
‡ Application was on the review clock for 10.0 months of the 19.4 month first review cycle, and therefore it met
the PDUFA 10 month review time goal.
Next page: Appendix C: Completion of PDUFA III Goals Not Part of PDUFA IV
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