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Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics)

About the Accelerated Approval Regulations

NDAs

NDA Supplements

BLAs

BLA Supplements

 

NDA's

 

NDA Number Proprietary Name Established Name Receipt Date Approval Date Total Approval Time Approval Basis Indication
22187 Intelence etravirine 18-Jul-07 18-Jan-08 6.0 S Provides for the treatment in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
22145 Isentress raltegravir 13-Apr-07 12-Oct-07 6.0 S Provides for the treatment in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
22068 Tasigna nilotinib hydrochloride monohydrate 29-Sep-06 29-Oct-07 13.0 S Provides for chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patient resistant to or intolerant to prior therapy that included Gleeves (imatinib).
22128 Selzentry maraviroc 20-Dec-06 6-Aug-07 6.0 S Provides for the treatment of patients infected with CCR5-tropic HIV-1.
21986 Sprycel dasatinib 28-Dec-05 28-Jun-06 6.0 S Provides for the use of Sprycel (dasatinib) Tablets for the treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib.
21976 Prezista darunavir 23-Dec-05 23-Jun-06 6.0 S Provides for the use of Prezista (darunavir) tablets, coadministered with 100 mg of ritonavir, for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1
strains resistant to more than one protease inhibitor.
22081 Letairis ambrisentan 18-Dec-06 15-Jun-07 5.9 R Provides for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
21880 Revlimid lenalidomide 7-Apr-05 27-Dec-05 8.7 R Provides for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
21882 Exjade deferasirox 2-May-05 2-Nov-05 6.0 S Provides for the use of Exjade® (deferasirox) Tablets for Oral Suspension for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
21877 Arranon nelarabine 29-Apr-05 28-Oct-05 6.0 S Provides for the use of Arranon (nelarabine) Injection for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
21814 Aptivus tipranavir 22-Dec-04 22-Jun-05 6.0 S Provides for the use of Aptivus® (tipranavir) capsules, 250 mg, coadministered with 200 mg of ritonavir, for combination antiretroviral treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors.
21673 Clolar clofarabine 30-Mar-04 28-Dec-04 8.9 S Provides for the use of Clolar (clofarabine) intravenous infusion for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
21322 Luveris lutropin alfa 1-May-01 8-Oct-04 41.3 S Provides for the use of Luveris® 75IU (lutropin alfa for injection), concomitantly administered with Gonal-f ® (follitropin alfa for injection) for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH < 1.2 IU/L)
21752 Truvada emtricitabine; tenofovir 12-Mar-04 2-Aug-04 4.7 S Provides for the use of Truvada™ (emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg)) tablets in combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults
21320 Plenaxis abarelix 12-Dec-00 25-Nov-03 35.4 R Provides for the use of Plenaxis (abarelix for injectable suspension, 100 mg) for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia
21602 Velcade bortezomib 21-Jan-03 13-May-03 3.7 S Provides for the use of Velcade (bortezomib) for Injection for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy
21399 Iressa gefitinib 5-Aug-02 5-May-03 9.0 S Provides for the use of IRESSA (gefitinib tablets) as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies
21588 Gleevec imatinib mesylate 16-Dec-02 18-Apr-03 4.0 S Provides for the use of Gleevec (imatinib mesylate) 100 mg and 400 mg tablets for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alfa therapy
21481 Fuzeon enfuvirtide 16-Sep-02 13-Mar-03 5.9 S Provides for the use of Fuzeon (enfuvirtide) for injection, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy
21492 Eloxatin oxaliplatin 24-Jun-02 9-Aug-02 1.5 S Provides for the use of Eloxatin (oxaliplatin) for Injection in combination with infusional 5-FU/LV for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/LV and irinotecan
21196 Xyrem sodium oxybate 2-Oct-00 17-Jul-02 21.5 R Provides for the use of Xyrem Oral Solution for the treatment of cataplexy associated with narcolepsy
21272 Remodulin treprostinil sodium 16-Oct-00 21-May-02 19.1 S Provides for the use of Remodulin (treprostinil sodium) Injection 1.0, 2.5, 5.0, and 10.0 mg/ml for the treatment of pulmonary arterial hypertension (PAH)
21290 Tracleer bosentan 17-Nov-00 20-Nov-01 12.1 R Treatment of pulmonary arterial hypertension
21356 Viread tenofovir disoproxil fumarate 1-May-01 26-Oct-01 5.9 S In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults
21335 Gleevec imatinib mesylate 27-Feb-01 10-May-01 2.4 S Provides for the use of Gleevec (imatinib mesylate) 50 and 100 mg capsules for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy
21205 Trizivir abacavir sulfate, lamivudine, and zidovudine 17-Dec-99 14-Nov-00 10.9 S Provides for the use of Trizivir either alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection
20687 Mifeprex mifepristone 18-Mar-96 28-Sep-00 18.0e  R For medical termination of intrauterine pregnancy through 49 days' pregnancy
21226 Kaletra lopinavir/ritonavir 1-Jun-00 15-Sep-00 3.5 S Kaletra in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients age six months and older
21251 Kaletra lopinavir/ritonavir 1-Jun-00 15-Sep-00 3.5 S Kaletra in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients age six months and older
21174 Mylotarg gemtuzumab ozogamicin 29-Oct-99 17-May-00 6.6 S Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy
50747 Synercid quinupristin/dalfopristin 5-Sep-97 21-Sep-99 7.8d S Treatment of vancomycin resistant Enterococcus faecium
21029 Temodar temozolomide 13-Aug-98 11-Aug-99 11.9 S Treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine
21007 Agenerase amprenavir 16-Oct-98 15-Apr-99 6 S Provides for the use of Agenerase (amprenavir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection
21039 Agenerase amprenavir 8-Dec-98 15-Apr-99 4.2 S Provides for the use of Agenerase (amprenavir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection
21041 DepoCyt cytarabine 5-Oct-98 1-Apr-99 5.9 S Depocyt is indicated for the intrathecal treatment of lymphomatous meningitis
20977 Ziagen abacavir sulfate 24-Jun-98 17-Dec-98 5.8 S Provides for the use of Ziagen (abacavir sulfate), in combination with other antiretroviral agents, for the treatment of HIV-1 infection
20978 Ziagen abacavir sulfate 24-Jun-98 17-Dec-98 5.8 S Provides for the use of Ziagen (abacavir sulfate), in combination with other antiretroviral agents, for the treatment of HIV-1 infection
20747 Actiq fentanyl citrate 13-Nov-96 4-Nov-98 23.7 R For the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain
20972 Sustiva efavirenz 11-Jun-98 17-Sep-98 3.2 S Provides for the use of efavirenz in combination with other antiretroviral agents for the treatment of HIV-1 infection
20933 Viramune nevirapine 20-Apr-98 11-Sep-98 4.7 S Provides for an oral suspension, which is indicated for use in combination therapy with other antiretroviral agents for the treatment of HIV-1 infection
20785 Thalomid thalidomide 20-Dec-96 16-Jul-98 18.8 R Thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences
21024 Priftin rifapentine 22-Dec-97 22-Jun-98 6 S Priftin is indicated for the treatment of pulmonary tuberculosis (TB)
19832 Sulfamylon mafenide acetate 31-Mar-97 5-Jun-98 14.2 c S Indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds
20896 Xeloda capecitabine 31-Oct-97 30-Apr-98 6 S Treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated
20705 Rescriptor delavirdine mesylate 15-Jul-96 4-Apr-97 8.7 S Treatment of HIV infection in combination with appropriate antiretroviral agents when therapy is warranted
20778 Viracept nelfinavir mesylate 26-Dec-96 14-Mar-97 2.6 S Treatment of HIV infection when therapy is warranted
20779 Viracept nelfinavir mesylate 26-Dec-96 14-Mar-97 2.6 S Treatment of HIV infection when therapy is warranted
19815 ProAmatine midodrine hydrochloride 25-Sep-95 6-Sep-96 11.4 b S Treatment of symptomatic orthostatic hypotension
20604 Serostim somatropin 11-Sep-95 23-Aug-96 11.4 S Treatment of AIDS wasting associated with catabolism loss or cachexia
20636 Viramune nevirapine 23-Feb-96 21-Jun-96 3.9 S Combination with nucleoside analogues for the treatment of HIV-1 infected adults who have experienced clinical and/or immunologic deterioration
20571 Camptosar irinotecan hydrochloride 28-Dec-95 14-Jun-96 5.6 S Treatment of refractory colorectal cancer
20449 Taxotere docetaxel 27-Jul-94 14-May-96 21.6 S Treatment of patients with locally advanced or metastatic breast cancer who have progressed or relapsed during anthracycline based therapy
20685 Crixivan indinavir sulfate 31-Jan-96 13-Mar-96 1.4 S Treatment of HIV infection in adults
20659 Norvir ritonavir 21-Dec-95 1-Mar-96 2.3 S In combination with nucleoside analogues or as monotherapy for the treatment of HIV infection
20680 Norvir ritonavir 21-Dec-95 1-Mar-96 2.3 S In combination with nucleoside analogues or as monotherapy for the treatment of HIV infection
20628 Invirase saquinavir mesylate 31-Aug-95 6-Dec-95 3.2 S Treatment of advanced HIV infection in selected patients in combination with nucleoside analogues
20564 Epivir lamivudine 7-Jul-95 17-Nov-95 4.4 S Treatment of HIV infection in selected patients
20596 Epivir lamivudine 7-Jul-95 17-Nov-95 4.4 S Treatment of HIV infection in selected patients
50718 Doxil doxorubicin hydrochloride 2-Sep-94 17-Nov-95 14.3 S Treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy
20498 Casodex bicalutamide 14-Sep-94 4-Oct-95 12.7 S Use in combination therapy with a Luteinizing-Hormone Releasing Hormone (LHRH) analogue for the treatment of advanced prostate cancer
20212 Zinecard dexrazoxane 5-Aug-94 26-May-95 9.7 a S To reduce the incidence and severity of cardiomyopathy associated with doxorubicin administration in certain breast cancer patients
20412 Zerit stavudine 28-Dec-93 24-Jun-94 5.9 S Treatment of adults with advanced HIV infection - alternative  therapy
50698 Biaxin clarithromycin 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to Mycobacterium avium and Mycobacterium intracellular
20199 Hivid zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection
 

 NDA Supplements Approved Under Subpart H

 

NDA Number NDA Supp Number Proprietary Name Established Name Receipt Date Approval Date Total Approval Time Approval Basis Indication
50718 SE7 033 Doxil doxorubicin hydrochloride liposome 10-Aug-07 10-Jun-08 10.0 S Provides for the treatment of AIDS-related Kaposi's Sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy.
20634 SE5 047 Levaquin levofloxacin 05-Jul-07 05-May-08 10.0 S Provides for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in pediatric patients (>6 month of age and older)(Tablets).
20635 SE5 051 Levaquin levofloxacin 05-Jul-07 05-May-08 10.0 S Provides for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in pediatric patients (>6 month of age and older)(Injection).
21721 SE5 015 Levaquin levofloxacin 05-Jul-07 05-May-08 10.0 S Provides for inhalational anthrax(post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in pediatric patients (>6 month of age and older)(Oral Solution).
21588 SE1 016 Gleevec imatinib mesylate 28-Mar-06 27-Sep-06 6.0 S Provides for the use of Gleevec for newly diagnosed Philadelphia chromosome positive CML in pediatric patients.
21880 SE1 001 Revlimid lenalidomide 30-Dec-05 29-Jun-06 6.0 R Provides for the use of Revlimid® 15 mg and 25 mg capsules in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
21430 N Thalomid thalidomide 23-Dec-03 25-May-06 29.0 R, S Treatment of patients with newly diagnosed multiple myeloma.
20785 SLR Thalomid thalidomide 24-May-05 25-May-06 12.0 R, S Treatment of patients with newly diagnosed multiple myeloma.
21968 N Sutent sunitinib malate 11-Aug-05 26-Jan-06 5.5 S Provides for the use of SUTENT® (sunitinib malate) Capsules for the treatment of advanced renal cell carcinoma.
20726 SE1 012 Femara letrozole 28-Jun-05 28-Dec-05 6.0 S Provides for the use of Femara® (letrozole tablets) for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
18662 SLR Accutane isotretinoin 27-Jun-05 12-Aug-05 1.5 R Because of the teratogenicity of isotretinoin, this supplement proposes the iPLEDGE program, an enhanced risk minimization action plan (RiskMAP) designed to minimize drug exposure during pregnancy.
21272 SE3 002 Remodulin treprostinil sodium 30-Jan-04 24-Nov-04 9.8 S Provides for adding the infusion of Remodulin (treprostinil sodium) 1, 2.5, 5 & 10 mg/mL Injection via an indwelling central venous catheter to the labeling
21721 SE1 003 Levaquin levofloxacin 12-Nov-04 24-Nov-04 0.4 S Provides for the use of Levaquin® oral solution for the treatment of inhalational anthrax (post-exposure)
20635 SE1 035 Levaquin levofloxacin 26-May-04 24-Nov-04 6.0 S Provides for the use of Levaquin® injection for the treatment of inhalational anthrax (post-exposure)
20634 SE1 035 Levaquin levofloxacin 26-May-04 24-Nov-04 6.0 S Provides for the use of Levaquin® tablets for the treatment of inhalational anthrax (post-exposure)
20726 SE1 011 Femara letrozole 29-Apr-04 29-Oct-04 6.0 S Provides for the use of Femara for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received five years of adjuvant tamoxifen therapy.
21677 N Alimta pemetrexed 4-Nov-03 19-Aug-04 9.5 S Provides for the use of Alimta® (pemetrexed for injection) as a single-agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.
21335 SE5 003 Gleevec imatinib mesylate 28-Jun-02 20-May-03 10.7 S Provides for the use of Gleevec (imatinib mesylate) tablets for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon-alfa therapy.  There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
21588 SE5 001 Gleevec imatinib mesylate 24-Apr-03 20-May-03 0.9 S Provides for the use of Gleevec (imatinib mesylate) Tablets for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon-alfa therapy.  There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
21335 SE1 004 Gleevec imatinib mesylate 28-Jun-02 20-Dec-02 5.8 S Provides for the use of Gleevec (imatinib mesylate), 100 mg capsules for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML).  Follow-up is limited.
20541 SE1 010 Arimidex anastrozole 5-Mar-02 5-Sep-02 6.0 S Provides for the use of ARIMIDEX (anastrozole) Tablets for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
21107 SE8 005 Lotronex alosetron hydrochloride 7-Dec-01 7-Jun-02 6.0 R Provides for the use of Lotronex only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:  chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and failed to respond to conventional therapy
21335 SE1 001 Gleevec imatinib mesylate 16-Oct-01 1-Feb-02 3.6 S Provides for the use of Gleevec (imatinib mesylate) for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)
19537 SE1 038 Cipro ciprofloxacin hydrochloride 1-Mar-00 30-Aug-00 6.0 S Provides for the use of CIPRO for inhalational anthrax (post-exposure)
19847 SE1 024 Cipro ciprofloxacin hydrochloride 2-Mar-00 30-Aug-00 6.0 S Provides for the use of CIPRO for inhalational anthrax (post-exposure)
19857 SE1 027 Cipro ciprofloxacin hydrochloride 2-Mar-00 30-Aug-00 6.0 S Provides for the use of CIPRO for inhalational anthrax (post-exposure)
19858 SE1 021 Cipro ciprofloxacin hydrochloride 2-Mar-00 30-Aug-00 6.0 S Provides for the use of CIPRO for inhalational anthrax (post-exposure)
20780 SE1 008 Cipro ciprofloxacin hydrochloride 2-Mar-00 30-Aug-00 6.0 S Provides for the use of CIPRO for inhalational anthrax (post-exposure)
21156 N Celebrex celecoxib 25-Jun-99 23-Dec-99 6.0 S To reduce the number of adenomatous colorectal polyps in Familial Adenomatous Polyposis (FAP), as an adjunct to usual care
50718 SE1 006 Doxil doxorubicin hydrochloride 29-Dec-98 28-Jun-99 6.0 S Treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens
20636 SE1 009 Viramune nevirapine 16-Mar-98 11-Sep-98 5.9 S Provides for the inclusion of pediatric information into the labeling
20221 SE1 002 Ethyol amifostine 9-Feb-96 15-Mar-96 1.2 S Provides for modification of Ethyol indications, to include treatment of patients with non-small cell lung cancer
50697 N Biaxin clarithromycin 2-Nov-92 23-Dec-93 13.7 S Provides for the treatment of disseminated mycobacterial infections due to Mycobacterium avium and Mycobacterium intracellular

 

BLAs Approved Under Subpart E

 

Submission Tracking #
Proprietary Name Proper Name Receipt Date Approval Date AP Time Approval Basis Indication
     BL125147 Vectibix panitumumab 29-Mar-06 27-Sep-06 6.0 S Provides for the treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
BL125104 Tysabri natalizumab 24-May-04 23-Nov-04 6.0 S Treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations.
BL125084 Erbitux cetuximab 14-Aug-03 12-Feb-04 6.0 S Treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in combination with irinotecan); Treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy (administered as a single agent)
 
BL103979 Fabrazyme agalsidase beta 23-Jun-00 24-Apr-03 34.1 S Use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types
 
BL125019 Zevalin ibritumomab tiuxetan 1-Nov-00 19-Feb-02 15.6 S Treatment of patients with relapsed or refractory low grade, follicular, or transformed B-cell non-Hodgkin's
lymphoma
 
BL103948 Campath alemtuzumab 23-Dec-99 7-May-01 16.5 S Treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy
 
BL103767 Ontak denileukin diftitox 9-Dec-97 5-Feb-99 13.9 S Treatment of persistent or recurrent cutaneous T-cell lymphoma
 
BL103772 Remicade infliximab 30-Dec-97 24-Aug-98 7.8 S Treatment of moderately to severely active Crohn's
disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s)
 
BL103471 Betaseron interferon beta-1b 18-Jun-92 23-Jul-93 13.2 S Treatment of multiple sclerosis

 

 

BLA Supplements Approved Under Subpart E

 

Submission Tracking #
Proprietary Name Proper Name Receipt Date Approval Date AP Time Approval Basis Indication
BL125085/91.0 bevacizumab

Genentech

24-May-06 22-Feb-08 21.4 S Provides for the use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer.
BL103948/5070 Alemtuzumab campath 20-Mar-07 19-Sep-07 6.0 S Provides for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy.
BL125104/15.0 Tysabri natalizumab 26-Sep-05 5-Jun-06 8.3 R Provides for the use of TYSABRI for the treatment of patients with relapsing forms of multiple sclerosis (MS) to delay the accumulation of physical disability and reduce the frequency of
clinical exacerbations.  Add a Boxed Warning and update several sections of the package insert.
BL125011/24.0 Bexxar tositumomab and iodine I 131 tositumomab 3-Jul-04 22-Dec-04 5.6 S Expands the indication to include patients with relapsed or refractory, low grade, follicular or transformed CD20 positive non-Hodgkin's lymphoma who have not received rituximab

 

 

The Therapeutic Biologic Products transferred from CBER to CDER effective 1-Oct-03.
R - Restricted - Approval with restrictions to assure safe use as recorded in 21 CFR 601.42 (Subpart E).
S - Surrogate - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity as recorded in 21 CFR 601.41 (Subpart E).

Updated quarterly through 06/30/08