NDAs Approved under Subpart H

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FDA/Center for Drug Evaluation and Research

NDAs Approved under Subpart H

Updated quarterly through 9/30/04.

Date created: October 25, 2004

Under Subpart H, approval may be based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity ("Surrogate") [21 CFR 314.510], or a product may be approved with restrictions to assure safe use ("Restricted" ) [21 CFR 314.520]. (See Table below)

[21 CFR 314.510] Surrogate - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.   Approval under this section will be subject to the requirement that the applicant study the drug further, to verify and describe its clinical benefit, where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical benefit to ultimate outcome. Postmarketing studies would usually be studies already underway. When required to be conducted, such studies must also be adequate and well-controlled. The applicant shall carry out any such studies with due diligence.

[21 CFR 314.520]   Restricted - Approval with restrictions to assure safe use.

   (a) If FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the drug product, such as:

(1) Distribution restricted to certain facilities or physicians with special training or experience; or
(2) Distribution conditioned on the performance of specified medical procedures.
(3) The limitations imposed will be commensurate with the specific safety concerns presented by the drug product.

NDA # Trade Name Generic Name Receipt Date Approval Date AP Time Approval Basis Indication

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-alpha 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 18.0^e 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 7.8^d 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

^a -- Approval time based on the receipt of significant new clinical data on 8/4/94 supporting a new indication. The original receipt date of this application was 2/10/92.
^b -- Significant new clinical data needed for approval was received on 9/25/95; before this only partial clinical data had been received. This date was used to calculate total approval time. The original receipt date was (28-Apr-88).

^c -- Significant new clinical data supporting a new indication were received on 31-Mar-97. This date was used to calculate the total approval time. The original receipt date was 19-Feb-88.

^d -- The total approval time was adjusted for N050747 because of a negative plant inspection. The time period until an acceptable inspection was received (05-Mar-98 to 26-Jul-99) was excluded from this time.

^e -- The total approval time for N020687, Mifeprex was adjusted. The time period from 9-18-96 to 8-19-99 was excluded because the sponsor had to find a new manufacturer, the final study report for the US Clinical trial was completed and submitted late in

R - Restricted - Approval with restrictions to assure safe use as recorded in 21 CFR 314.520 (Subpart H).

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 314.510 (Subpart H).

Type 6 NDAs follow the same performance rules as efficacy supplements and are included with supplement approvals.