Drugs

Efficacy Supplement Approvals in 2001

 

EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001
(SE1 -SE7)*
and
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001
(SE8)*

 

GENERIC NAMEAPPLICANTNDA NUMBERRECEIPT DATEAPPROVAL DATESUPP TYPESUPP NUMBERPRIORITY
REVIEW 
TOTAL APPROVAL TIME (MONTHS)INDICATION/DESCRIPTION
13C-UREAMERETEK20-58610-Jul-0010-May-01SE2004N10.0Provides for a decrease in dose of 13C-urea from 125 mg to 75 mg in the BreathTekTM UBT Collection Kit.
ALENDRONATE SODIUMMERCK20-56031-Mar-0031-Jan-01SE2025N10.1Provides for the consideration of using Fosamax 70 mg in men once weekly for the treatment to increase bone mass in men with osteoporosis.
AMPRENAVIRGLAXO WELLCOME21-00714-Jul-0011-May-01SE7006N9.9Provides for the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection.
AMPRENAVIRGLAXO WELLCOME21-03914-Jul-0011-May-01SE7006N9.9Provides for the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection.
AZITHROMYCINPFIZER50-71016-Feb-0114-Dec-01SE2008N9.9Provides for the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 1-day dosing regimen.
AZITHROMYCINPFIZER50-71016-Feb-0114-Dec-01SE2009N9.9Provides for the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 3-day dosing regimen.
BETAMETHASONE DIPROPIONATESCHERING17-5365-Oct-003-Oct-01SE5024X11.9Provides for labeling revisions. Specifically, S-024 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Cream, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-018.
BETAMETHASONE DIPROPIONATESCHERING17-6915-Oct-003-Oct-01SE5024X11.9Provides for labeling revisions. Specifically, S-024 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Ointment, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-019.
BETAMETHASONE DIPROPIONATESCHERING17-7815-Oct-003-Oct-01SE5022X11.9Provides for labeling revisions. Specifically, S-022 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Lotion, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-015.
BETAMETHASONE DIPROPIONATESCHERING19-5555-Oct-003-Oct-01SE5016X11.9Provides for labeling revisions. Specifically, S-016 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROLENE AF Cream in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-008.
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTIONALLERGAN20-49015-Aug-0120-Dec-01SE5007N4.2Proposes a change in the wording of the pediatric section of the package inserts.
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTIONALLERGAN20-61315-Aug-0120-Dec-01SE5018N4.2Proposes a change in the wording of the pediatric section of the package inserts.
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTIONALLERGAN21-26215-Aug-0120-Dec-01SE5006N4.2Proposes a change in the wording of the pediatric section of the package inserts.
BUSPIRONE HCLBRISTOL MYERS SQUIBB18-73121-Mar-0019-Jul-01SE5043N15.9Provides for new language for pediatric use.
BUTENAFINE HCLBERTEK PHARMS20-5247-Aug-006-Jun-01SE1005N10.0Provides for the use of Mentax (butenafine HCl cream) Cream, 1%, for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum orbiculare).
BUTENAFINE HYDROCHLORIDESCHERING PLOUGH21-30729-Sep-007-Dec-01N000N14.3Provides for the use without prescription of Lotrimin Ultra butenafine hydrochloride cream 1%, for the topical treatment of the following superficial dermatophytoses: interdigital tinea pedis (athlete's foot), tinea corporis (ringworm) and tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans.
CAPCITABINEHLR20-8968-Mar-017-Sep-01SE7010Y6.0Provides for the use of Xeloda (capcitabine) Tablets in combination with Taxotere (docetaxel) for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.
CAPECITABINEHLR20-89620-Sep-9930-Apr-01SE1006N19.3Provides for the use of XELOD as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred.
CARVEDILOLGLAXO SMITH KLINE20-2972-Mar-011-Nov-01SE1007N8.0Provides for the use of Coreg (carvedilol) 3.125, 6.25, 12.5 and 25 mg Tablets for severe heart failure.
CELECOXIB CAPSULESEARLE20-99819-Dec-0018-Oct-01SE1010N10.0Provides for the use of Celebrex (celecoxib capsule) Capsules 100 mg, and 200 mg for the management of acute pain in adults and the treatment of primary dysmenorrhea.
CLARITHROMYCIN EXTENDED RELEASE TABLETSABBOTT LABS50-7752-Oct-002-Aug-01SE1001N10.0Provides for addition of Community-Acquired Pneumonia due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Chlamydia pneumonia (TWAR), Legionella pneumophila or Mycoplasma Pneumoniae to the BIAXIN XL Filmtab label.
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESCHERING18-8275-Oct-003-Oct-01SE5022X11.9Provides final pediatric study reports and a safety update in response to the Pediatric Written Request and supersedes S-007, S-009, and S-020.
CROMOLYN SODIUM NASAL SOLUTIONPHARMACIA UPJOHN20-46331-Aug-9927-Mar-01SE5002N18.9Provides for the use of NasalCrom Nasal Solution (cromolyn sodium nasal solution) nasal spray for use in children down to 2 years of age.
DELAVIRDINE MESYLATEAGOURON20-70517-Jul-0016-May-01SE7008N10.0Provides for the use of RESCRIPTOR for the treatment of HIV-1 infection in combination with at least 2 other active antiretroviral agents when therapy is warranted.
DOPAMINE HCL AND 5% DEXTROSE INJECTION IN PLASTIC CONTAINERBAXTER HLTHCARE19-61524-Jun-9917-Apr-01SE5012N21.8Provides for final printed labeling revised as follows: Changes in the PRECAUTIONS, Pediatric Use subsection and the addition of a new Pediatric Dosing and Administration subsection under DOSAGE and ADMINISTRATION.
EPTIFIBATIDECOR20-71830-Jun-008-Jun-01SE2010N11.3Provides for labeling revised to reflect the findings of the ESPRIT ("Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (the 'ESPRIT Study); A Phase III Study in Patients Undergoing Percutaneous Coronary Intervention with Stent Implantation") study. The revisions include a new dosing recommendation for patients undergoing Percutaneous Coronary Intervention (PCI) and a revised recommended target range for the activated clotting time (ACT) during PCI.
ESOMEPRAZOLE MAGNESIUMASTRAZENECA21-15428-Feb-0020-Feb-01N000N11.8Provides for the use of Nexium (esomeprazole magnesium) Delayed-Release Capsules in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease or a history of duodenal ulcer disease.
ESTRADIOL TRANSDERMAL SYSTEMBERLEX LABS20-3755-Jun-005-Apr-01SE1016N10.0Provides for the use of the 0.025 mg/day Climara (Estradiol transdermal System) for the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated with the menopause.
FLUOCINOLONE ACETONIDEHILL DERM19-45210-Oct-0010-Oct-01SE5017N12.0Provides for the use of Derma-Smoothe/FS in pediatric patients 2 years and older for the treatment of atopic dermatitis.
GATIFLOXACINBRISTOL MYERS SQUIBB21-06121-Dec-0012-Oct-01SE2007N9.7Provides for a change in the dosing regimen for the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration.
GATIFLOXACINBRISTOL MYERS SQUIBB21-0623-Jan-0112-Oct-01SE2008N9.3Provides for a change in the dosing regimen for the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration.
INSULIN ASPART [rDNA ORIGIN] INJECTIONNOVO NORDISK PHARM20-98621-Dec-0021-Dec-01SE3003N12.0Provides for the use of NovoLog with the following external insulin pumps: 1. Disertronic H-TRON plus V100 with Disertronic 3.15 plastic cartridges and Classic or Tender infusion sets, or 2. MiniMed Models 505, 506, or 507 with Minimed 3 mL syringes and Polyfin or Sof-set infusion sets.
IRBESARTANSANOFI SYNTHELABO20-75717-Feb-0026-May-01SE5014N15.3Provides for final printed labeling revised as follows: Under CLINICAL PHARMACOLOGY, the Special Populations, the Pediatric subsection has been changed. Under PRECAUTIONS, Pediatric Use, a second paragraph has been added. Under DOSAGE and ADMINISTRATION, a Pediatric Patients subsection has been added. Under HOW SUPPLIED, the 75 mg Blister Pack of 100 (NDC# 0087-2771-35) has been removed.
ITRACONAZOLEJANSSEN20-6571-May-009-May-01SE1005N12.3Provides for the use of Sporanox Injection for empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN).
ITRACONAZOLEJANSSEN20-9661-May-009-May-01SE1004N12.3Provides for the use of Sporanox Injection for empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN).
LAMIVUDINEGLAXO WELLCOME21-00328-Feb-0116-Aug-01SE1002N5.6Provides for the use of Epivir-HBV in the treatment of hepatitis B in pediatric patients ages 2-17 years.
LAMIVUDINEGLAXO WELLCOME21-00428-Feb-0116-Aug-01SE1002N5.6Provides for the use of Epivir-HBV in the treatment of hepatitis B in pediatric patients ages 2-17 years.
LETROZOLENOVARTIS PHARMS20-72612-Jul-0010-Jan-01SE1006Y6.0Provides for the use of Femara for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.
LEUPROLIDE ACETATE FOR DEPOT SUSPENSIONTAP PHARM20-01122-Nov-0021-Sep-01SE1021N10.0Provides for the use of Lupron Depot 3.75 mg monthly with norethindrone acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months.
LEUPROLIDE ACETATE FOR DEPOT SUSPENSIONTAP PHARM20-70822-Nov-0021-Sep-01SE1011N10.0Provides for the use of Lupron Depot-3 Month 11.25 mg with norethindrone acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months.
METOPROLOL SUCCINATEASTRAZENECA19-96210-Sep-995-Feb-01SE1013N16.9Provides for the new use of Toprol-XL (metoprolol succinate) Tablets for the treatment of congestive heart failure and for a 25 mg dosage strength scored tablet.
MICONAZOLE NITRATE 1200 MG SOFT GEL VAGINAL INSERT AND MICONAZOLE NITRATE CREAM, 2%PERSONAL PRODS21-3081-Sep-0029-Jun-01N000N9.9Provides for the use of MONISTAT 1 COMBINATION PACK for the treatment of vulvovaginal candidiasis.
MOXIFLOXACIN HCLBAYER21-33410-Dec-9827-Apr-01N000N28.6Provides for the use of Avelox for the treatment of uncomplicated skin and skin structure infections.
NORETHINDRONE ACETATE, 1MG, AND ETHINYL ESTRADIOL, 35MCGPARKE DAVIS21-2763-Jul-001-Jul-01N000N11.9Provides for the use of ESTROSTEP 21 and ESTROSTEP Fe Tablets for the treatment of moderate acne vulgaris in females, >15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.
PAMIDRONATE DISODIUM INJECTIONNOVARTIS PHARM20-03613-Aug-0120-Aug-01SE2024N0.2Proposes to change the administration rate for the infusion of Aredia from 24 hours to 2 to 24 hours. This change applies to the indication for the treatment of moderate and severe hypercalcemia of malignancy, with or without bone metastases.
PANTOPRAZOLE SODIUMWYETH AYERST LABS20-98712-Jun-0012-Jun-01SE1001N12.0Proposes the use of PROTONIX (pantoprazole sodium) Delayed-Release Tablets for the following new indication: Maintenance of Healing of Erosive Esophagitis and control of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD).
PANTOPRAZOLE SODIUMWYETH AYERST LABS20-98820-Apr-0119-Oct-01SE1003Y6.0Provides for the use of Protonix I.V. for Injection in the treatment of pathological hypersecretion associated with Zollinger-Ellison Syndrome (ZES).
PAROXETINE HCLSKB PHARMS20-03128-Apr-0013-Apr-01SE1026N11.5Provides for the use of Paxil (paroxetine hydrochloride) Tablets for the treatment of generalized anxiety disorder as a new indication.
PAROXETINE HYDROCHLORIDESKB PHARMS20-03121-Jul-0014-Dec-01SE1029N16.8Provides for the use of Paxil (paroxetine hydrochloride) Tablets for the treatment of posttraumatic stress disorder as a new indication.
PRAVASTATIN SODIUMBRISTOL MYERS SQUIBB19-8981-Mar-0118-Dec-01SE2046N9.6Provides for the use of a new dosage strength (80 mg) and dosing regimen (80 mg once per day) of Pravachol (pravastatin sodium) tablets.
PROPOFOLASTRAZENECA UK19-62721-May-9923-Feb-01SE5035N21.2Provides for the use of Diprivan (propofol) Injectable Emulsion in patients 3 months to 16 years old for general anesthesia.
SIBUTRAMINE HCL MONOHYDRATEKNOLL PHARM20-63218-Apr-0016-Feb-01SE2011N10.0Provides for an addition to the CLINICAL STUDIES and the DOSAGE AND ADMINISTRATION sections of the labeling indicating the maintenance of weight loss over an 18 month period thus extending the use of this drug from 1 year to 2 years.
SOMATROPIN [rDNA origin] FOR INJECTIONPHARMACIA AND UPJOHN20-2803-Jul-0025-Jul-01SE1031Y12.7Provides for the use of Genotropin (somatropin [rDNA origin] for injection) for long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by two years of age.
TAZAROTENEALLERGAN21-18411-Dec-0011-Oct-01SE1001N10.0Provides for the use of Tazorac (tazarotene) Cream, 0.1% for acne vulgaris.
TICLOPIDINE HCLSYNTEX (USA) LLC19-97924-Jan-0018-Apr-01SE1018N14.8Provides for the new use of Ticlid (ticlopidine hydrochloride) Tablets as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation.
TOPIRAMATEJOHNSON RW20-5051-Aug-9728-Aug-01SE1002N48.9Provides for the use of Topamax (topiramate) Tablets as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome.
TOPIRAMATEJOHNSON RW20-8448-Jun-0128-Aug-01SE1010N2.7Provides for the use of Topamax (topiramate) Sprinkle Capsule as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome.
TRIMETHOBENZAMIDE HYDROCHLORIDEKING PHARMS17-53114-Feb-0113-Dec-01SE2010N9.9Provides for the following in response to the Federal Register notice of January 9, 1979, classifying this drug effective for postoperative nausea and vomiting and nausea associated with gastroenteritis: draft labeling, results of bioavailability studies, and updated manufacturing and controls and testing procedures.
VALACYCLOVIR HCLGLAXO WELLCOME20-55031-Aug-0025-Jun-01SE2012N9.8Provides for a labeling indication for a shorter treatment course of three days in the treatment of recurrent episodes of genital herpes.
VENLAFAXINE HCLWYETH AYERST LABS20-15119-May-002-May-01SE1017N11.4Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depression.
VENLAFAXINE HCLWYETH AYERST LABS20-15122-May-002-May-01SE1018N11.3Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depression.
VENLAFAXINE HCLWYETH AYERST LABS20-6995-May-002-May-01SE1015N11.9Provides for the use of Effexor XR Capsules for the prevention of recurrence of depression and for the prevention of relapse of depression.
VENLAFAXINE HCLWYETH AYERST LABS20-69922-May-002-May-01SE1016N11.3Provides for the use of Effexor XR Capsules for the prevention of recurrence of depression and for the prevention of relapse of depression.
VERTEPORFIN FOR INJECTIONQLT21-11914-Aug-0022-Aug-01SE1001Y12.3Provides for the use of Visudyne (verteporfin for injection) therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis or pathologic myopia.
ZAFIRLUKASTASTRAZENECA20-54730-Jun-0027-Apr-01SE1014N9.9Provides for the use of Accolate 10mg for the prophylaxis and chronic treatment of asthma in pediatric patients 5 - 6 years of age.


*Supplement TypeDescription for SE1 - SE7
N (Chemical Type 6)
SE1
SE2
SE3
SE4
SE5
SE6
SE7
NDA Type 6 - New Indication
New or modified indication
New dosage regimen
New route of administration
Comparative efficacy claim
Patient population altered
Change the marketing status from prescription to over the counter use
Complete the traditional approval of a product originally approved under subpart H (accelerated approval)

          This list is updated quarterly.  Updated through 12/31/01.

      

 EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001
(SE8)*
GENERIC NAMEAPPLICANTNDA NUMBERRECEIPT DATEAPPROVAL DATESUPP TYPESUPP NUMBERPRIORITY REVIEWTOTAL APPROVAL TIME (MONTHS)
ADENOSINEFUJISAWA HLTHCARE20-05911-Aug-9931-Aug-01SE8007N24.7
ATORVASTATIN CALCIUMPFIZER20-70211-Aug-008-Jun-01SE8025N9.9
BUDESONIDEASTRAZENECA20-74626-Dec-0026-Oct-01SE8004N10.0
BUPROPION HCLGLAXO WELLCOME20-71127-Apr-007-Feb-01SE8012N9.4
BUPROPION HYDROCHLORIDEGLAXO WELLCOME20-3581-Jun-0011-Jun-01SE8019N12.3
CALCITRIOL INJECTIONABBOTT LABS18-87419-Jan-0116-Nov-01SE8016N9.9
DANAPAROID SODIUMORGANON20-43028-Aug-0026-Jun-01SE8003N9.9
ENALAPRIL MALEATEMERCK18-99814-Jan-0013-Feb-01SE8059N13.0
LAMOTRIGINEGLAXO WELLCOME20-2414-Nov-9925-May-01SE8011N18.7
LAMOTRIGINEGLAXO WELLCOME20-7644-Nov-9925-May-01SE8005N18.7
LANSOPRAZOLETAP PHARM20-4061-May-001-May-01SE8038N12.0
METFORMIN HCLBRISTOL MYERS SQUIBB20-35719-Jun-0019-Apr-01SE8020N10.0
MONTELUKAST SODIUMMERCK20-83026-May-0023-Nov-01SE8011N18.0
PRAVASTATIN SODIUMBRISTOL MYERS SQUIBB19-89821-Aug-0015-Jun-01SE8042N9.8
RIBAVIRINSCHERING PLOUGH RES20-9031-Mar-0128-Dec-01SE8013X9.9
SERTRALINE HCLPFIZER PHARMS19-8391-Jun-006-Aug-01SE8035N14.2
SERTRALINE HCLPFIZER PHARMS20-9901-Jun-006-Aug-01SE8003N14.2
SERTRALINE HYDROCHLORIDEPFIZER PHARMS19-8393-Apr-0012-Oct-01SE8033N18.3
SERTRALINE HYDROCHLORIDEPFIZER PHARMS20-9903-Apr-0012-Oct-01SE8001N18.3
SEVOFLURANEABBOTT20-4781-Jun-0030-Mar-01SE8006N9.9
SIBUTRAMINE HCL MONOHYDRATEKNOLL PHARM20-63218-Apr-0016-Feb-01SE8008N10.0
SODIUM FERRIC GLUCONATER AND D LABS20-9552-Aug-002-Feb-01SE8003Y6.0
SOTALOL HYDROCHLORIDEBERLEX LABS19-86519-Oct-991-Oct-01SE8010N23.4
TOLTERODINE TARTRATEPHARMACIA AND UPJOHN20-77123-Dec-996-Apr-01SE8004N15.5
VINORELBINE TARTRATEGLAXO WELLCOME20-3887-Apr-002-Oct-01SE8010N17.9
ZALEPLONWYETH AYERST LABS20-85929-Oct-9922-Feb-01SE8001N15.8

 

*Supplement TypeDescription for SE8
SE8Incorporate other information based on at least one adequate and well controlled clinical study.

 

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