Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics)
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=""> |
| 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