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U.S. Department of Health and Human Services

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Efficacy Supplement Approvals in 2001

 

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

 

GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY
REVIEW 
TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION
13C-UREA MERETEK 20-586 10-Jul-00 10-May-01 SE2 004 N 10.0 Provides for a decrease in dose of 13C-urea from 125 mg to 75 mg in the BreathTekTM UBT Collection Kit.
ALENDRONATE SODIUM MERCK 20-560 31-Mar-00 31-Jan-01 SE2 025 N 10.1 Provides for the consideration of using Fosamax 70 mg in men once weekly for the treatment to increase bone mass in men with osteoporosis.
AMPRENAVIR GLAXO WELLCOME 21-007 14-Jul-00 11-May-01 SE7 006 N 9.9 Provides for the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection.
AMPRENAVIR GLAXO WELLCOME 21-039 14-Jul-00 11-May-01 SE7 006 N 9.9 Provides for the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection.
AZITHROMYCIN PFIZER 50-710 16-Feb-01 14-Dec-01 SE2 008 N 9.9 Provides for the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 1-day dosing regimen.
AZITHROMYCIN PFIZER 50-710 16-Feb-01 14-Dec-01 SE2 009 N 9.9 Provides for the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 3-day dosing regimen.
BETAMETHASONE DIPROPIONATE SCHERING 17-536 5-Oct-00 3-Oct-01 SE5 024 X 11.9 Provides 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 DIPROPIONATE SCHERING 17-691 5-Oct-00 3-Oct-01 SE5 024 X 11.9 Provides 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 DIPROPIONATE SCHERING 17-781 5-Oct-00 3-Oct-01 SE5 022 X 11.9 Provides 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 DIPROPIONATE SCHERING 19-555 5-Oct-00 3-Oct-01 SE5 016 X 11.9 Provides 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 SOLUTION ALLERGAN 20-490 15-Aug-01 20-Dec-01 SE5 007 N 4.2 Proposes a change in the wording of the pediatric section of the package inserts.
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION ALLERGAN 20-613 15-Aug-01 20-Dec-01 SE5 018 N 4.2 Proposes a change in the wording of the pediatric section of the package inserts.
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION ALLERGAN 21-262 15-Aug-01 20-Dec-01 SE5 006 N 4.2 Proposes a change in the wording of the pediatric section of the package inserts.
BUSPIRONE HCL BRISTOL MYERS SQUIBB 18-731 21-Mar-00 19-Jul-01 SE5 043 N 15.9 Provides for new language for pediatric use.
BUTENAFINE HCL BERTEK PHARMS 20-524 7-Aug-00 6-Jun-01 SE1 005 N 10.0 Provides 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 HYDROCHLORIDE SCHERING PLOUGH 21-307 29-Sep-00 7-Dec-01 N 000 N 14.3 Provides 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.
CAPCITABINE HLR 20-896 8-Mar-01 7-Sep-01 SE7 010 Y 6.0 Provides 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.
CAPECITABINE HLR 20-896 20-Sep-99 30-Apr-01 SE1 006 N 19.3 Provides for the use of XELOD as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred.
CARVEDILOL GLAXO SMITH KLINE 20-297 2-Mar-01 1-Nov-01 SE1 007 N 8.0 Provides for the use of Coreg (carvedilol) 3.125, 6.25, 12.5 and 25 mg Tablets for severe heart failure.
CELECOXIB CAPSULE SEARLE 20-998 19-Dec-00 18-Oct-01 SE1 010 N 10.0 Provides 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 TABLETS ABBOTT LABS 50-775 2-Oct-00 2-Aug-01 SE1 001 N 10.0 Provides 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 DIPROPIONATE SCHERING 18-827 5-Oct-00 3-Oct-01 SE5 022 X 11.9 Provides 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 SOLUTION PHARMACIA UPJOHN 20-463 31-Aug-99 27-Mar-01 SE5 002 N 18.9 Provides for the use of NasalCrom Nasal Solution (cromolyn sodium nasal solution) nasal spray for use in children down to 2 years of age.
DELAVIRDINE MESYLATE AGOURON 20-705 17-Jul-00 16-May-01 SE7 008 N 10.0 Provides 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 CONTAINER BAXTER HLTHCARE 19-615 24-Jun-99 17-Apr-01 SE5 012 N 21.8 Provides 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.
EPTIFIBATIDE COR 20-718 30-Jun-00 8-Jun-01 SE2 010 N 11.3 Provides 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 MAGNESIUM ASTRAZENECA 21-154 28-Feb-00 20-Feb-01 N 000 N 11.8 Provides 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 SYSTEM BERLEX LABS 20-375 5-Jun-00 5-Apr-01 SE1 016 N 10.0 Provides 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 ACETONIDE HILL DERM 19-452 10-Oct-00 10-Oct-01 SE5 017 N 12.0 Provides for the use of Derma-Smoothe/FS in pediatric patients 2 years and older for the treatment of atopic dermatitis.
GATIFLOXACIN BRISTOL MYERS SQUIBB 21-061 21-Dec-00 12-Oct-01 SE2 007 N 9.7 Provides for a change in the dosing regimen for the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration.
GATIFLOXACIN BRISTOL MYERS SQUIBB 21-062 3-Jan-01 12-Oct-01 SE2 008 N 9.3 Provides 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] INJECTION NOVO NORDISK PHARM 20-986 21-Dec-00 21-Dec-01 SE3 003 N 12.0 Provides 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.
IRBESARTAN SANOFI SYNTHELABO 20-757 17-Feb-00 26-May-01 SE5 014 N 15.3 Provides 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.
ITRACONAZOLE JANSSEN 20-657 1-May-00 9-May-01 SE1 005 N 12.3 Provides for the use of Sporanox Injection for empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN).
ITRACONAZOLE JANSSEN 20-966 1-May-00 9-May-01 SE1 004 N 12.3 Provides for the use of Sporanox Injection for empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN).
LAMIVUDINE GLAXO WELLCOME 21-003 28-Feb-01 16-Aug-01 SE1 002 N 5.6 Provides for the use of Epivir-HBV in the treatment of hepatitis B in pediatric patients ages 2-17 years.
LAMIVUDINE GLAXO WELLCOME 21-004 28-Feb-01 16-Aug-01 SE1 002 N 5.6 Provides for the use of Epivir-HBV in the treatment of hepatitis B in pediatric patients ages 2-17 years.
LETROZOLE NOVARTIS PHARMS 20-726 12-Jul-00 10-Jan-01 SE1 006 Y 6.0 Provides 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 SUSPENSION TAP PHARM 20-011 22-Nov-00 21-Sep-01 SE1 021 N 10.0 Provides 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 SUSPENSION TAP PHARM 20-708 22-Nov-00 21-Sep-01 SE1 011 N 10.0 Provides 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 SUCCINATE ASTRAZENECA 19-962 10-Sep-99 5-Feb-01 SE1 013 N 16.9 Provides 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 PRODS 21-308 1-Sep-00 29-Jun-01 N 000 N 9.9 Provides for the use of MONISTAT 1 COMBINATION PACK for the treatment of vulvovaginal candidiasis.
MOXIFLOXACIN HCL BAYER 21-334 10-Dec-98 27-Apr-01 N 000 N 28.6 Provides for the use of Avelox for the treatment of uncomplicated skin and skin structure infections.
NORETHINDRONE ACETATE, 1MG, AND ETHINYL ESTRADIOL, 35MCG PARKE DAVIS 21-276 3-Jul-00 1-Jul-01 N 000 N 11.9 Provides 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 INJECTION NOVARTIS PHARM 20-036 13-Aug-01 20-Aug-01 SE2 024 N 0.2 Proposes 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 SODIUM WYETH AYERST LABS 20-987 12-Jun-00 12-Jun-01 SE1 001 N 12.0 Proposes 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 SODIUM WYETH AYERST LABS 20-988 20-Apr-01 19-Oct-01 SE1 003 Y 6.0 Provides for the use of Protonix I.V. for Injection in the treatment of pathological hypersecretion associated with Zollinger-Ellison Syndrome (ZES).
PAROXETINE HCL SKB PHARMS 20-031 28-Apr-00 13-Apr-01 SE1 026 N 11.5 Provides for the use of Paxil (paroxetine hydrochloride) Tablets for the treatment of generalized anxiety disorder as a new indication.
PAROXETINE HYDROCHLORIDE SKB PHARMS 20-031 21-Jul-00 14-Dec-01 SE1 029 N 16.8 Provides for the use of Paxil (paroxetine hydrochloride) Tablets for the treatment of posttraumatic stress disorder as a new indication.
PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB 19-898 1-Mar-01 18-Dec-01 SE2 046 N 9.6 Provides for the use of a new dosage strength (80 mg) and dosing regimen (80 mg once per day) of Pravachol (pravastatin sodium) tablets.
PROPOFOL ASTRAZENECA UK 19-627 21-May-99 23-Feb-01 SE5 035 N 21.2 Provides for the use of Diprivan (propofol) Injectable Emulsion in patients 3 months to 16 years old for general anesthesia.
SIBUTRAMINE HCL MONOHYDRATE KNOLL PHARM 20-632 18-Apr-00 16-Feb-01 SE2 011 N 10.0 Provides 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 INJECTION PHARMACIA AND UPJOHN 20-280 3-Jul-00 25-Jul-01 SE1 031 Y 12.7 Provides 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.
TAZAROTENE ALLERGAN 21-184 11-Dec-00 11-Oct-01 SE1 001 N 10.0 Provides for the use of Tazorac (tazarotene) Cream, 0.1% for acne vulgaris.
TICLOPIDINE HCL SYNTEX (USA) LLC 19-979 24-Jan-00 18-Apr-01 SE1 018 N 14.8 Provides 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.
TOPIRAMATE JOHNSON RW 20-505 1-Aug-97 28-Aug-01 SE1 002 N 48.9 Provides for the use of Topamax (topiramate) Tablets as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome.
TOPIRAMATE JOHNSON RW 20-844 8-Jun-01 28-Aug-01 SE1 010 N 2.7 Provides 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 HYDROCHLORIDE KING PHARMS 17-531 14-Feb-01 13-Dec-01 SE2 010 N 9.9 Provides 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 HCL GLAXO WELLCOME 20-550 31-Aug-00 25-Jun-01 SE2 012 N 9.8 Provides for a labeling indication for a shorter treatment course of three days in the treatment of recurrent episodes of genital herpes.
VENLAFAXINE HCL WYETH AYERST LABS 20-151 19-May-00 2-May-01 SE1 017 N 11.4 Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depression.
VENLAFAXINE HCL WYETH AYERST LABS 20-151 22-May-00 2-May-01 SE1 018 N 11.3 Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depression.
VENLAFAXINE HCL WYETH AYERST LABS 20-699 5-May-00 2-May-01 SE1 015 N 11.9 Provides for the use of Effexor XR Capsules for the prevention of recurrence of depression and for the prevention of relapse of depression.
VENLAFAXINE HCL WYETH AYERST LABS 20-699 22-May-00 2-May-01 SE1 016 N 11.3 Provides for the use of Effexor XR Capsules for the prevention of recurrence of depression and for the prevention of relapse of depression.
VERTEPORFIN FOR INJECTION QLT 21-119 14-Aug-00 22-Aug-01 SE1 001 Y 12.3 Provides 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.
ZAFIRLUKAST ASTRAZENECA 20-547 30-Jun-00 27-Apr-01 SE1 014 N 9.9 Provides for the use of Accolate 10mg for the prophylaxis and chronic treatment of asthma in pediatric patients 5 - 6 years of age.


 
*Supplement Type Description 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 NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS)
ADENOSINE FUJISAWA HLTHCARE 20-059 11-Aug-99 31-Aug-01 SE8 007 N 24.7
ATORVASTATIN CALCIUM PFIZER 20-702 11-Aug-00 8-Jun-01 SE8 025 N 9.9
BUDESONIDE ASTRAZENECA 20-746 26-Dec-00 26-Oct-01 SE8 004 N 10.0
BUPROPION HCL GLAXO WELLCOME 20-711 27-Apr-00 7-Feb-01 SE8 012 N 9.4
BUPROPION HYDROCHLORIDE GLAXO WELLCOME 20-358 1-Jun-00 11-Jun-01 SE8 019 N 12.3
CALCITRIOL INJECTION ABBOTT LABS 18-874 19-Jan-01 16-Nov-01 SE8 016 N 9.9
DANAPAROID SODIUM ORGANON 20-430 28-Aug-00 26-Jun-01 SE8 003 N 9.9
ENALAPRIL MALEATE MERCK 18-998 14-Jan-00 13-Feb-01 SE8 059 N 13.0
LAMOTRIGINE GLAXO WELLCOME 20-241 4-Nov-99 25-May-01 SE8 011 N 18.7
LAMOTRIGINE GLAXO WELLCOME 20-764 4-Nov-99 25-May-01 SE8 005 N 18.7
LANSOPRAZOLE TAP PHARM 20-406 1-May-00 1-May-01 SE8 038 N 12.0
METFORMIN HCL BRISTOL MYERS SQUIBB 20-357 19-Jun-00 19-Apr-01 SE8 020 N 10.0
MONTELUKAST SODIUM MERCK 20-830 26-May-00 23-Nov-01 SE8 011 N 18.0
PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB 19-898 21-Aug-00 15-Jun-01 SE8 042 N 9.8
RIBAVIRIN SCHERING PLOUGH RES 20-903 1-Mar-01 28-Dec-01 SE8 013 X 9.9
SERTRALINE HCL PFIZER PHARMS 19-839 1-Jun-00 6-Aug-01 SE8 035 N 14.2
SERTRALINE HCL PFIZER PHARMS 20-990 1-Jun-00 6-Aug-01 SE8 003 N 14.2
SERTRALINE HYDROCHLORIDE PFIZER PHARMS 19-839 3-Apr-00 12-Oct-01 SE8 033 N 18.3
SERTRALINE HYDROCHLORIDE PFIZER PHARMS 20-990 3-Apr-00 12-Oct-01 SE8 001 N 18.3
SEVOFLURANE ABBOTT 20-478 1-Jun-00 30-Mar-01 SE8 006 N 9.9
SIBUTRAMINE HCL MONOHYDRATE KNOLL PHARM 20-632 18-Apr-00 16-Feb-01 SE8 008 N 10.0
SODIUM FERRIC GLUCONATE R AND D LABS 20-955 2-Aug-00 2-Feb-01 SE8 003 Y 6.0
SOTALOL HYDROCHLORIDE BERLEX LABS 19-865 19-Oct-99 1-Oct-01 SE8 010 N 23.4
TOLTERODINE TARTRATE PHARMACIA AND UPJOHN 20-771 23-Dec-99 6-Apr-01 SE8 004 N 15.5
VINORELBINE TARTRATE GLAXO WELLCOME 20-388 7-Apr-00 2-Oct-01 SE8 010 N 17.9
ZALEPLON WYETH AYERST LABS 20-859 29-Oct-99 22-Feb-01 SE8 001 N 15.8

 

*Supplement Type Description for SE8
SE8 Incorporate other information based on at least one adequate and well controlled clinical study.