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Efficacy Supplement Approvals in 2003

EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003
(SE1 -SE7)*

SUPP TYPE APPROVAL DATE

GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION
FLUOXETINE HYDROCHLORIDE

LILLY RES LABS

18-936

SE5

064

15-Sep-00

3-Jan-03

 

27.6

Provides for the use of Prozac in the treatment of major depressive disorder (MDD) and obsessive compulsive disorder (OCD) in the pediatric population.

CASPOFUNGIN ACETATE

MERCK RES

21-227

SE1

007

7-Mar-02

7-Jan-03

 

10.1

Provides for the use of Cancidas (caspofungin acetate) For Injection for the treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections.

BUSULFAN

ORPHAN MEDCL

20-954

SE2

004

28-Dec-01

13-Jan-03

Y

12.5

Proposes a change to the package insert for Busulfex (busulfan) Injection by incorporating pediatric information on dosing, pharmacokinetics and safety.

LAMOTRIGINE

GLAXOSMITHKLINE

20-241

SE1

008

29-Jan-99

17-Jan-03

 

47.6

Provides for the use of Lamictal (lamotrigine) Tablets as adjunctive therapy of partial seizures in pediatric patients greater than or equal to 2 years of age.

LAMOTRIGINE

GLAXOSMITHKLINE

20-764

SE1

002

29-Jan-99

17-Jan-03

 

47.6

Provides for the use of Lamictal (lamotrigine) Chewable Dispersible Tablets as adjunctive therapy of partial seizures in pediatric patients greater than or equal to 2 years of age.

NIACIN

KOS PHARMS

20-381

SE1

013

1-Apr-02

31-Jan-03

 

10.0

Provides for the use of Niaspan (niacin extended-release) Tablets in combination with lovastatin as an adjunct to exercise and diet for the treatment of adult patients with dyslipidemia.

SERTRALINE HYDROCHLORIDE

PFIZER

19-839

SE1

045

22-Jan-02

7-Feb-03

 

12.5

Provides for the use of Zoloft (sertraline hydrochloride) Tablets for the treatment of social anxiety disorder as a new indication.

SERTRALINE HYDROCHLORIDE

PFIZER

20-990

SE1

011

22-Jan-02

7-Feb-03

 

12.5

Provides for the use of Zoloft (sertraline hydrochloride) Oral Concentrate for the treatment of social anxiety disorder as a new indication.

VENLAFAXINE HYDROCHLORIDE

WYETH AYERST

20-699

SE1

022

12-Sep-01

11-Feb-03

 

17.0

Provides for the use of Effexor XR (venlafaxine hydrochloride) Extended-release Capsules for the treatment of social anxiety disorder as a new indication.

POLIFEPROSAN 20 WITH CARMUSTINE

GUILFORD PHARMS

20-637

SE1

016

6-Apr-01

25-Feb-03

Y

22.7

Proposes to expand the indication to include patients with malignant glioma undergoing primary surgical resection.

ROSIGLITAZONE MALEATE

GLAXOSMITHKLINE

21-071

SE1

004

8-Feb-00

27-Feb-03

 

36.7

Proposes a new indication for the use of Avandia in combination with insulin for the treatment of patients with Type 2 diabetes mellitus.

TECHNETIUM TC99M TETROFOSMIN KIT

AMERSHAM HLTH

20-372

SE1

013

29-Apr-02

28-Feb-03

 

10.0

Proposes to expand the indication for Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection) to include the assessment of ventricular function in subjects being evaluated for heart disease and/or ventricular function.

MOXIFLOXACIN HYDROCHLORIDE

BAYER

21-085

SE1

015

18-Dec-02

28-Feb-03

 

2.4

Provides for the modification of the indication for Community Acquired Pneumonia to add "(including penicillin-resistant strains, MIC penicillin > 2μg/mL)" to Streptococcus pneumoniae.

MOXIFLOXACIN HYDROCHLORIDE

BAYER

21-277

SE1

007

18-Dec-02

28-Feb-03

 

2.4

Provides for the modification of the indication for Community Acquired Pneumonia to add "(including penicillin-resistant strains, MIC penicillin > 2μg/mL)" to Streptococcus pneumoniae.

CONJUGATED ESTROGENS / MEDROXYPROGESTERONE ACETATE

WYETH AYERST

20-527

SE2

017

15-Jun-00

12-Mar-03

 

32.9

Provides for the use of PREMPRO (0.45 mg conjugated estrogen/1.5 mg medroxyprogesterone acetate) in a continuous combined regimen for: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

CEFEPIME HYDROCHLORIDE

BRISTOL MYERS SQUIBB

50-679

SE2

021

22-May-02

17-Mar-03

 

9.8

Provides for labeling revisions for dosing hemodialysis patients.

LOSARTAN POTASSIUM

MERCK

20-386

SE1

032

26-Jul-02

25-Mar-03

Y

8.0

Provides for a new use of Cozaar (losartan potassium) 25, 50 and 100 mg Tablets to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. The Indications section further notes that there is evidence that this benefit does not apply to Black patients.

CARVEDILOL

GLAXOSMITHKLINE

20-297

SE1

009

27-Sep-02

27-Mar-03

Y

6.0

Provides for the use of Coreg (carvedilol) 3.125, 6.25, 12.5 and 25 mg Tablets for the treatment of patients with left ventricular dysfunction following myocardial infarction.

VALACYCLOVIR HYDROCHLORIDE

GLAXOSMITHKLINE

20-550

SE1

005

24-Apr-97

1-Apr-03

 

71.3

Provides for the use of Valtrex (valacyclovir hydrochloride) 500 mg Caplets for the suppression of recurrent genital herpes in HIV-infected individuals.

SIROLIMUS

WYETH PHARMS INC

21-083

SE1

006

9-Apr-01

11-Apr-03

 

24.1

Provides for the use of Rapamune (sirolimus) Oral Solution within an immunosuppressive regimen that would allow for the withdrawal of cyclosporine 2 to 4 months after renal transplantation in patients considered at low to moderate immunologic risk for renal transplant rejection.

SIROLIMUS

WYETH PHARMS INC

21-110

SE1

004

18-Apr-01

11-Apr-03

 

23.8

Provides for the use of Rapamune (sirolimus) Tablets within an immunosuppressive regimen that would allow for the withdrawal of cyclosporine 2 to 4 months after renal transplantation in patients considered at low to moderate immunologic risk for renal transplant rejection.

OXYBUTYNIN CHLORIDE

ALZA

20-897

SE5

009

7-Dec-01

15-Apr-03

 

16.2

Provides for the use of DITROPAN XL (oxybutynin chloride) Extended Release Tablets for the treatment of overactive bladder in children aged six years of age and older.

SIMVASTATIN

MERCK

19-766

SE1

058

19-Jun-02

16-Apr-03

 

9.9

Provides for a new indication, based on the results of the Heart Protection Study (HPS), for the use of simvastatin in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease to reduce the risk of total mortality by reducing coronary death, to reduce the risk of non-fatal myocardial infarction and stroke, and to reduce the need for coronary and non-coronary revascularization procedures. In addition, this supplemental application provides for changes to the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the ZOCOR package insert.

CONJUGATED ESTROGENS, USP

WYETH PHARMS INC

04-782

SE2

115

31-Jul-00

24-Apr-03

 

32.8

Provides for the use of Premarin (0.45 mg) for the treatment of moderate to-severe vasomotor symptoms associated with the menopause and for the treatment of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Also provides for revisions in the text of the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION AND HOW SUPPLIED sections of the package insert, and the text of the patient package insert.

PIPERACILLIN SODIUM / TAZOBACTAM SODIUM

WYETH PHARMS INC

50-684

SE2

033

28-Jun-02

28-Apr-03

 

10.0

Proposes to revise the dosing regimen for nosocomial pneumonia from 3.375 grams given every 4 hours to 4.5 grams given every 6 hours.

INSULIN GLARGINE [rDNA ORIGIN] 

AVENTIS PHARMS

21-081

SE2

005

1-Jul-02

1-May-03

 

10.0

Provides for the change of dosing schedule for Lantus from once daily at bedtime to flexible dosing. Lantus (insulin glargine [rDNA origin] injection) is indicated for once daily subcutaneous administration in the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM

WYETH PHARMS

50-750

SE2

008

9-Jan-03

6-May-03

 

3.8

Proposes to revise the dosing regimen for nosocomial pneumonia from 3.375 grams given every 4 hours to 4.5 grams given every 6 hours.

DOXORUBICIN HYDROCHLORIDE

PHARMACIA AND UPJOHN

50-467

SE1

068

8-Apr-02

8-May-03

 

13.0

Provides for the use of Doxorubicin Hydrochloride for Injection for use in combination with cyclophosphamide as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

DOXORUBICIN HYDROCHLORIDE

PHARMACIA AND UPJOHN

50-629

SE1

014

12-Apr-02

8-May-03

 

12.9

Provides for the use of Doxorubicin Hydrochloride Injection for use in combination with cyclophosphamide as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

IMATINIB MESYLATE

NOVARTIS

21-335

SE5

003

28-Jun-02

20-May-03

Y

10.7

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 alpha therapy. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

IMATINIB MESYLATE

NOVARTIS

21-588

SE5

001

24-Apr-03

20-May-03

Y

0.9

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 alpha therapy. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

FENTANYL

ALZA

19-813

SE1

036

26-Nov-02

20-May-03

Y

5.8

Provides for the use of Duragesic (Fentanyl Transdermal System) in opioid-telerant pediatric patients 2 years of age and older.

LEVOFLOXACIN

ORTHO MCNEIL PHARM

20-634

SE1

027

29-Jul-02

23-May-03

 

9.8

Provides for the use of Levaquin Tablets for the treatment of chronic bacterial prostatitis.

LEVOFLOXACIN

ORTHO MCNEIL PHARM

20-635

SE1

026

29-Jul-02

23-May-03

 

9.8

Provides for the use of Levaquin Injection for the treatment of chronic bacterial prostatitis.

FOSINOPRIL SODIUM

BRISTOL MYERS SQUIBB

19-915

SE5

037

27-Nov-02

27-May-03

Y

6.0

Proposes changes to the CLINICAL PHARMACOLOGY, PRECAUTIONS, ADVERSE REACTIONS, OVERDOSAGE, and DOSAGE AND ADMINISTRATION sections of the labeling concerning the use of Monopril in pediatric patients.

FLUVASTATIN SODIUM

NOVARTIS

20-261

SE1

033

1-Aug-02

27-May-03

 

9.8

Provides for a new indication, based on the results of the Lescol Intervention Prevention Study (LIPS), for the use of fluvastatin in patients with coronary heart disease to reduce the risk of undergoing coronary revascularization procedures. In addition, this supplemental application provides for changes to the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, and ADVERSE REACTIONS sections of the LESCOL package insert.

FLUVASTATIN SODIUM

NOVARTIS

21-192

SE1

005

1-Aug-02

27-May-03

 

9.8

Provides for a new indication, based on the results of the Lescol Intervention Prevention Study (LIPS), for the use of fluvastatin in patients with coronary heart disease to reduce the risk of undergoing coronary revascularization procedures. In addition, this supplemental application provides for changes to the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, and ADVERSE REACTIONS sections of the LESCOL XL package insert.

LISINOPRIL

MERCK

19-558

SE5

043

25-Sep-01

29-May-03

 

20.1

Proposes changes to the CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling concerning the use of Prinivil (lisinopril) in pediatric patients.

IRON SUCROSE

LUITPOLD

21-135

SE2

006

2-Aug-02

2-Jun-03

 

10.0

Provides additional safety information for the use of Venofer for the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

CONJUGATED ESTROGENS / MEDROXYPROGESTERONE ACETATE

WYETH PHARMS

20-527

SE1

024

7-Nov-01

4-Jun-03

 

18.9

Provides for an additional strength of PREMPRO (0.3 mg conjugated estrogens / 1.5 mg medroxyprogesterone acetate) continuous combined regimen for the treatment of moderate-to-severe vasomotor symptoms associated with the menopause, and the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, tropical vaginal products should be considered.

LEFLUNOMIDE

AVENTIS PHARMS

20-905

SE1

006

31-Aug-00

13-Jun-03

Y

33.4

Provides for the use of Arava (leflunomide) tablets, for rheumatoid arthritis. Specifically, the supplemental NDA S-006 provides for revised labeling to support the addition of a claim for improved physical function.

FONDAPARINUX SODIUM

FONDA BV

21-345

SE1

002

17-Dec-02

17-Jun-03

Y

6.0

Provides for the use of Arixtra (fondaparinux sodium) injection for extended prophylaxis in patients undergoing hip fracture surgery.

ATROPINE

MERIDIAN MEDCL TECHN

17-106

SE5

028

27-Dec-02

19-Jun-03

Y

5.7

Provides for use of the AtroPen Autoinjector in pediatric populations and includes information to support two lower strength AtroPen autoinjectors (0.5 mg and 1 mg) and a revised package insert for use in both adult and pediatric populations.

LAMOTRIGINE

GLAXOSMITHKLINE

20-241

SE1

017

6-Jun-02

20-Jun-03

 

12.5

Provides for the use of Lamictal (lamotrigine) Tablets for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.

LAMOTRIGINE

GLAXOSMITHKLINE

20-764

SE1

011

6-Jun-02

20-Jun-03

 

12.5

Provides for the use of Lamictal (lamotrigine) Chewable Dispersible Tablets for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.

HYDROXYUREA

BRISTOL MYERS SQUIBB

16-295

SE2

036

27-Aug-02

26-Jun-03

 

10.0

Provides for revisions to the labeling based on data obtained from a Phase 4 commitment study to determine the influence of renal impairment on the pharmacokinetics of hydroxyurea in adults with sickle cell disease.

FORMOTEROL FUMARATE

NOVARTIS

20-831

SE5

005

28-Aug-02

27-Jun-03

 

10.0

Provides for the use of Foradil Aerolizer (formoterol fumarate) Inhalation Powder for the prevention of EIB in children 5 years old and older.

LISINOPRIL

ASTRAZENECA

19-777

SE5

044

5-Nov-01

1-Jul-03

 

19.8

Proposes changes in the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, OVERDOSAGE and DOSAGE AND ADMINISTRATION sections of the labeling concerning the use of Zestril (lisinopril) in pediatric patients and revised safety information.

OLANZAPINE

LILLY

20-592

SE1

018

17-Sep-02

10-Jul-03

 

9.7

Provides for the use of olanzapine in combination with lithium or valproate for the treatment of acute manic episodes associated with bipolar disorder.

CONJUGATED ESTROGENS

WYETH PHARMS

21-417

N

000

18-Dec-01

16-Jul-03

 

18.9

Provides for the use of Premarin (conjugated estrogens tablets, USP) 0.3 gm and 0.45 mg for the prevention of postmenopausal osteoporosis.

SOMATROPIN [rDNA ORIGIN]

LILLY

19-640

SE1

033

26-Sep-02

25-Jul-03

 

9.9

Provides for the use of Humatrope for the long-term treatment of idiopathic short stature, also called non-growth hormone-deficient short stature, defined by height SDS < -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.

GEMIFLOXACIN MESYLATE

GENESOFT PHARMS

21-158

SE1

001

4-Jun-03

25-Jul-03

 

1.7

Provides for the use of Factive (gemifloxacin mesylate) Tablets for community-acquired pneumonia caused by Streptococcus pneumoniae including multi-drug resistant Streptococcus pneumoniae (MDRSP) strains.

PORFIMER SODIUM

AXCAN SCANDIPHARM

21-525

N

000

31-May-02

1-Aug-03

Y

14.0

Provides for the use of PHOTOFRIN (porfimer sodium) for Injection for the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.

OXCARBAZEPINE

NOVARTIS

21-014

SE5

003

12-Feb-01

7-Aug-03

 

29.8

Provides for the use of Trileptal as monotherapy in the treatment of partial seizures in children ages 4-16.

DIVALPROEX SODIUM

ABBOTT

21-168

SE5

007

14-Feb-03

14-Aug-03

Y

6.0

Provides for the use of Depakote ER (divalproex) tablets in pediatric patients for epilepsy.

TENOFOVIR DISOPROXIL FUMARATE

GILEAD

21-356

SE5

003

15-Oct-02

15-Aug-03

 

10.0

Provides for the use of VIREAD (tenofovir disoproxil fumarate) 300mg Tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection.

PAROXETINE HYDROCHLORIDE

GLAXOSMITHKLINE

20-936

SE1

011

26-Jun-02

28-Aug-03

 

14.1

Provides for the use of Paxil CR in the treatment of premenstrual dysphoric disorder (PMDD).

ARIPIPRAZOLE

OTSUKA

21-436

SE1

001

4-Dec-02

28-Aug-03

 

8.8

Provides for the longer-term efficacy of aripiprazole in the treatment of schizophrenia.

CIPROFLOXACIN

BAYER

21-554

N

000

29-Oct-02

28-Aug-03

 

10.0

Provides for the use of CIPRO XR (ciprofloxacin extended release tablets) for complicated urinary tract infections and acute uncomplicated pyelonephritis.

SOMATROPIN

SERONO

20-604

SE7

027

1-Nov-02

29-Aug-03

 

9.9

Provides for the use of Serostim [somatropin (rDNA origin) for injection] for HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance.

VALACYCLOVIR HYDROCHLORIDE

GLAXOSMITHKLINE

20-550

SE1

019

1-Nov-02

29-Aug-03

 

9.9

Provides for the use of Valtrex (valacyclovir hydrochloride) 500 mg Caplets in combination with safer sex practices for the reduction of the risk of transmission of genital herpes during suppressive therapy of the source partner in a heterosexual couple.

VALGANCICLOVIR HYDROCHLORIDE

ROCHE PALO

21-304

SE1

001

12-Nov-02

12-Sep-03

 

10.0

Provides for the use of Valcyte (valganciclovir hydrochloride) 450 mg Tablets for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative).

SERTRALINE HYDROCHLORIDE

PFIZER

19-839

SE5

044

17-Dec-01

16-Sep-03

 

21.0

Provides for additional safety data in the pediatric population.

SERTRALINE HYDROCHLORIDE

PFIZER

20-990

SE5

010

17-Dec-01

16-Sep-03

 

21.0

Provides for additional safety data in the pediatric population.

FAMOTIDINE

MERCK

20-325

SE2

015

22-Nov-02

23-Sep-03

 

10.0

Provides for a 20 mg nonprescription famotidine tablet.

LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE

MERCK

20-387

SE1

027

25-Sep-02

30-Sep-03

 

12.2

Provides for a new use of Hyzaar (losartan potassium/hydrochlorothiazide) 50-12.5 and 100-25 mg Tablets in the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients. In addition, this supplement provides for revisions to the DESCRIPTION, CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling.

OFLOXACIN

DAIICHI

20-799

SE2

006

29-Jan-01

30-Sep-03

 

32.0

Proposes once-a-day dosing of FLOXIN Otic for the treatment of adults and pediatric patients (ages 6 months and older) with Otitis Externa (OE) caused by susceptible strains of Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus.

EPLERENONE

GD SEARLE LLC

21-437

SE1

002

7-Apr-03

7-Oct-03

Y

6.0

Provides for the use of Inspra (eplerenone) Tablets to improve survival of stable patients with left ventricular systolic dysfunction (ejection fraction < 40%) and clinical evidence of congestive heart failure after an acute myocardial infarction.

PENCICLOVIR

NOVARTIS

20-629

SE5

008

11-Dec-02

10-Oct-03

 

10.0

Provides for the use of Denavir (penciclovir cream) 1% for the treatment of recurrent herpes labialis (RHL) in children 12 and older.

PAROXETINE HYDROCHLORIDE

GLAXOSMITHKLINE

20-936

SE1

012

20-Dec-02

16-Oct-03

 

9.9

Provides for the use of Paxil CR (paroxetine hydrochloride) Controlled-release Tablets for the treatment of social anxiety disorder as a new indication.

NATEGLINIDE

NOVARTIS

21-204

SE1

006

20-Dec-02

20-Oct-03

 

10.0

Provides for an expanded indication for the use of Starlix (nateglinide) Tablets, in combination with antidiabetic drugs in the thiazolidinedione class.

LEVOFLOXACIN

ORTHO MCNEIL PHARM

20-634

SE2

028

23-Dec-02

23-Oct-03

 

10.0

Provides for the use of Levaquin Tablets for Community Acquired Pneumonia (CAP) with a new dosing regimen of 750 mg, once daily for 5 days.

LEVOFLOXACIN

ORTHO MCNEIL PHARM

20-635

SE2

027

23-Dec-02

23-Oct-03

 

10.0

Provides for the use of Levaquin Injection for Community Acquired Pneumonia (CAP) with a new dosing regimen of 750 mg, once daily for 5 days.

VORICONAZOLE

PFIZER GLOBAL

21-464

N

000

17-Nov-00

14-Nov-03

 

35.9

Provides for the use of VFEND (voriconazole) Tablets for esophageal candidiasis.

VORICONAZOLE

PFIZER GLOBAL

21-466

N

000

17-Nov-00

14-Nov-03

 

35.9

Provides for the use of VFEND (voriconazole for injection) I.V. for esophageal candidiasis.

SALMETEROL XINAFOATE / FLUTICASONE PROPIONATE

GLAXOSMITHKLINE

21-077

SE1

003

7-May-01

17-Nov-03

 

30.4

Provides for the use of Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate inhalation powder) for Chronic Obstructive Pulmonary Disease associated with Chronic Bronchitis.

LORATADINE

SCHERING

19-658

SE6

020

28-Jan-02

19-Nov-03

 

21.7

Provides for over-the-counter use of Claritin (loratadine) Tablets for the relief of itching due to hives (urticaria) to be marketed under the tradename, Claritin Hives Relief.

LORATADINE

SCHERING

20-641

SE6

011

28-Jan-02

19-Nov-03

 

21.7

Provides for over-the-counter use of Claritin (loratadine) Syrup for the relief of itching due to hives (urticaria) to be marketed under the tradename, Claritin Hives Relief.

LORATADINE

SCHERING

20-704

SE6

009

28-Jan-02

19-Nov-03

 

21.7

Provides for over-the-counter use of Claritin (loratadine) Reditabs for the relief of itching due to hives (urticaria) to be marketed under the tradename, Claritin Hives Relief.

SOMATOTROPIN (RDNA ORIGIN)

SERONO INC

21-597

N

000

1-Nov-02

1-Dec-03

 

13.0

Provides for the use of Zorbtive [somatotropin (rDNA origin) for injection] for the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support.

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

GLAXOSMITHKLINE

21-078

SE5

006

2-Jun-03

2-Dec-03

Y

6.0

Provides for the use of Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets, 62.5 mg/25 mg for the treatment of Plasmodium falciparum malaria in pediatric patients weighing 5 kg to 11 kg.

RISPERIDONE

JANSSEN PHARMA

20-272

SE1

026

16-Dec-02

4-Dec-03

 

11.6

Provides for Monotherapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder

RISPERIDONE

JANSSEN PHARMA

20-272

SE1

027

16-Dec-02

4-Dec-03

 

11.6

Provides for Adjunctive Therapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder

RISPERIDONE

JANSSEN PHARM

20-588

SE1

017

16-Dec-02

4-Dec-03

 

11.6

Provides for Monotherapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder

RISPERIDONE

JANSSEN PHARM

20-588

SE1

018

16-Dec-02

4-Dec-03

 

11.6

Provides for Adjunctive Therapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder

RISPERIDONE

JOHNSON AND JOHNSON

21-444

SE1

002

15-Aug-03

4-Dec-03

 

3.6

Provides for Monotherapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder

RISPERIDONE

JOHNSON AND JOHNSON

21-444

SE1

003

15-Aug-03

4-Dec-03

 

3.6

Provides for Adjunctive Therapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder

IMATINIB MESYLATE

NOVARTIS PHARMS

21-588

SE7

002

28-Aug-03

8-Dec-03

 

3.4

Provides for a revised package insert with updated data and fulfills the prior accelerated postmarketing commitment #2 under NDA 21-588/N-000 "To provide interval follow-up information on studies 102, 109 and 110" for the use of Gleevec (imatinib mesylate) Tablets for the treatment of Patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

DALTEPARIN SODIUM

PHARMACIA AND UPJOHN

20-287

SE1

032

10-Feb-03

10-Dec-03

 

10.0

Provides for the use of Fragmin (dalteparin sodium) injection for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.

ORLISTAT

HOFFMANN-LAROCHE

20-766

SE5

018

24-Jun-03

12-Dec-03

Y

5.6

Provides for revised labeling to provide for use of Xenical Capsules in the management of obesity in adolescent patients aged 12 to 16 years.

TOPIRAMATE

ORTHO MCNEIL PHARM

20-505

SE2

017

1-Jul-02

16-Dec-03

 

17.5

Provides for a change in the recommended daily dose of topiramate and an update to the relevant clinical/safety sections of labeling based on results of the TOPMAT-EPAJ-119 study.

TOPIRAMATE

ORTHO MCNEIL

20-844

SE2

014

1-Jul-02

16-Dec-03

 

17.5

Provides for a change in the recommended daily dose of topiramate and an update to the relevant clinical/safety sections of labeling based on results of the TOPMAT-EPAJ-119 study.

ESCITALOPRAM OXALATE

FOREST LABS

21-323

SE1

003

27-Nov-02

18-Dec-03

 

12.7

Provides for the treatment of generalized anxiety disorder.

ESCITALOPRAM OXALATE

FOREST LABS

21-365

SE1

004

22-May-03

18-Dec-03

 

6.9

Provides for the treatment of generalized anxiety disorder.

SAQUINAVIR MESYLATE

HOFFMANN-LAROCHE

20-628

SE2

020

24-Feb-03

24-Dec-03

 

10.0

Provides for the use of INVIRASE (1000 mg twice daily) coadministered with ritonavir (100 mg twice daily) and in combination with other antiretroviral drugs, for the treatment of HIV infection. The new dosing regimen replaces the previously approved regimen for INVIRASE.

SAQUINAVIR MESYLATE

HOFFMANN-LAROCHE

20-828

SE2

015

24-Feb-03

24-Dec-03

 

10.0

Provides for the use of an additional dosing regimen of FORTOVASE (saquinavir) Soft Gelatin Capsules (1000 mg twice daily coadministered with ritonavir 100 mg twice daily) and in combination with other antiretroviral drugs, for the treatment of HIV infection.

 

*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)

 

EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003
(SE8)*

 

GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS)

VALSARTAN / HYDROCHLOROTHIAZIDE

NOVARTIS

20-818

SE8

016

12-Apr-02

15-Jan-03

 

9.1

LETROZOLE

NOVARTIS

20-726

SE8

008

18-Mar-02

17-Jan-03

 

10.0

PIOGLITAZONE HYDROCHLORIDE

TAKEDA PHARMS

21-073

SE8

017

18-Mar-02

17-Jan-03

 

10.0

GADOVERSETAMIDE

MALLINCKRODT

20-937

SE8

003

1-Apr-02

31-Jan-03

 

10.0

GADOVERSETAMIDE

MALLINCKRODT

20-975

SE8

003

1-Apr-02

31-Jan-03

 

10.0

GADOVERSETAMIDE

MALLINCKRODT

20-976

SE8

003

1-Apr-02

31-Jan-03

 

10.0

CYCLOBENZAPRINE HYDROCHLORIDE

MCNEIL CONS SPECLT

17-821

SE8

045

19-Apr-01

3-Feb-03

 

21.5

TRAVOPROST

ALCON UNIVERSAL

21-257

SE8

006

1-Jul-02

13-Feb-03

 

7.5

LETROZOLE

NOVARTIS

20-726

SE8

005

3-Jul-00

26-Feb-03

 

31.8

BUDESONIDE

ASTRAZENECA

20-929

SE8

013

3-Sep-02

26-Feb-03

 

5.8

TEMOZOLOMIDE

SCHERING

21-029

SE8

005

13-Sep-02

11-Mar-03

Y

5.9

CETIRIZINE HYDROCHLORIDE / PSEUDOEPHEDRINE HYDROCHLORIDE

PFIZER INC

21-150

SE8

002

14-Jun-02

14-Apr-03

 

10.0

OXYBUTYNIN CHLORIDE

ALZA

17-577

SE8

033

7-Dec-01

15-Apr-03

 

16.2

OXYBUTYNIN CHLORIDE

ALZA

18-211

SE8

016

7-Dec-01

15-Apr-03

 

16.2

FLUTICASONE PROPIONATE

GLAXOSMITHKLINE

20-121

SE8

028

1-Jul-02

1-May-03

 

10.0

DROSPIRENONE / ETHINYL ESTRADIOL

BERLEX LABS

21-098

SE8

005

12-Jul-02

9-May-03

 

9.9

FEXOFENADINE HYDROCHLORIDE

AVENTIS PHARMS

20-625

SE8

010

14-Jul-00

12-May-03

 

33.9

FEXOFENADINE HYDROCHLORIDE

AVENTIS PHARMS

20-625

SE8

012

20-Nov-02

12-May-03

Y

5.7

FEXOFENADINE HYDROCHLORIDE / PSEUDOEPHEDRINE HYDROCHLORIDE

AVENTIS PHARMS

20-786

SE8

014

19-Nov-02

12-May-03

Y

5.7

FEXOFENADINE HYDROCHLORIDE

AVENTIS PHARMS

20-872

SE8

003

14-Jul-00

12-May-03

 

33.9

FEXOFENADINE HYDROCHLORIDE

AVENTIS PHARMS

20-872

SE8

011

19-Nov-02

12-May-03

Y

5.7

EPTIFIBATIDE

MILLENNIUM PHARMS

20-718

SE8

017

21-Aug-02

16-Jun-03

 

9.8

CISATRACURIUM BESYLATE

ABBOTT

20-551

SE8

009

14-May-01

18-Jul-03

 

26.1

LINEZOLID

PHARMACIA AND UPJOHN

21-130

SE8

004

27-Sep-02

22-Jul-03

 

9.8

LINEZOLID

PHARMACIA AND UPJOHN

21-131

SE8

004

27-Sep-02

22-Jul-03

 

9.8

LINEZOLID

PHARMACIA AND UPJOHN

21-132

SE8

004

27-Sep-02

22-Jul-03

 

9.8

FLUDARABINE PHOSPHATE

BERLEX

20-038

SE8

028

10-Feb-03

1-Aug-03

Y

5.7

ROFECOXIB

MERCK

21-042

SE8

018

16-Oct-02

6-Aug-03

 

9.7

ROFECOXIB

MERCK

21-052

SE8

012

16-Oct-02

6-Aug-03

 

9.7

BOSENTAN

ACTELION

21-290

SE8

001

6-Dec-02

6-Oct-03

 

10.0

PIOGLITAZONE HYDROCHLORIDE

TAKEDA PHARMS NA

21-073

SE8

020

27-Jan-03

26-Nov-03

 

10.0

ESCITALOPRAM OXALATE

FOREST LABS

21-323

SE8

007

7-Feb-03

18-Dec-03

 

10.3

ESCITALOPRAM OXALATE

FOREST LABS

21-365

SE8

001

7-Feb-03

18-Dec-03

 

10.3

CHLORHEXIDINE GLUCONATE

XTTRIUM

19-422

SE8

032

25-Feb-02

19-Dec-03

 

21.8

FULVESTRANT

ASTRAZENECA

21-344

SE8

001

24-Feb-03

24-Dec-03

 

10.0

  

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

  This list is updated quarterly.  Updated through 12/31/03