Established Name
|
Applicant |
NDA
Number |
Supp
Type |
Supp
Number |
Review Class |
Receipt
Date
|
Approval
Date |
Total Approval Time (Months) |
Indication / Description
|
ciprofloxacin |
Bayer |
020780 |
SE7 |
016 |
S |
3/8/2004 |
1/7/2005 |
10.0 |
Provides for changes to the INDICATIONS
AND USAGE, ADVERSE REACTIONS, and INHALATIONAL ANTHRAX – ADDITIONAL
INFORMATION sections of the package insert based on the information
obtained from the Centers for Disease Control and Prevention program
evaluation conducted after the bioterror events of October 2001 |
ciprofloxacin |
Bayer |
019857 |
SE7 |
035 |
S |
3/8/2004 |
1/7/2005 |
10.0 |
Provides for changes to the INDICATIONS
AND USAGE, ADVERSE REACTIONS, and INHALATIONAL ANTHRAX – ADDITIONAL
INFORMATION sections of the package insert based on the information
obtained from the Centers for Disease Control and Prevention program
evaluation conducted after the bioterror events of October 2001 |
ciprofloxacin |
Bayer |
019847 |
SE7 |
030 |
S |
3/8/2004 |
1/7/2005 |
10.0 |
Provides for changes to the INDICATIONS
AND USAGE, ADVERSE REACTIONS, and INHALATIONAL ANTHRAX – ADDITIONAL
INFORMATION sections of the package insert based on the information
obtained from the Centers for Disease Control and Prevention program
evaluation conducted after the bioterror events of October 2001 |
ciprofloxacin hydrochloride |
Bayer |
019537 |
SE7 |
052 |
S |
3/8/2004 |
1/7/2005 |
10.0 |
Provides for changes to the INDICATIONS
AND USAGE, ADVERSE REACTIONS, and INHALATIONAL ANTHRAX – ADDITIONAL
INFORMATION sections of the package insert based on the information
obtained from the Centers for Disease Control and Prevention program
evaluation conducted after the bioterror events of October 2001 |
norethindrone acetate; ethinyl estradiol |
Warner Chilcott |
021065 |
SE2 |
012 |
S |
3/15/2004 |
1/14/2005 |
10.0 |
Provides for the use of femhrt® 0.5 mg/2.5 mcg (norethindrone acetate/ethinyl
estradiol tablets) in women with an intact uterus for the:
1. Treatment of moderate to severe vasomotor symptoms associated with
the menopause.
2. Prevention of postmenopausal osteoporosis. |
doxorubicin hydrochloride |
Alza |
050718 |
SE7 |
020 |
S |
3/29/2004 |
1/28/2005 |
10.0 |
Provides for the use of Doxil® for the treatment of patients with
ovarian cancer whose disease has progressed or recurred after
platinum-based chemotherapy. |
fentanyl |
Alza |
019813 |
SE2 |
039 |
S |
4/6/2004 |
2/4/2005 |
10.0 |
Provides for the use of Duragesic® (Fentanyl Transdermal System) 12
mcg/h patch for the management of persistent, moderate to severe chronic
pain that: requires continuous, around-the-clock opioid administration
for an extended period of time, and cannot be managed by other means
such as non-steroidal analgesics, opioid combination products, or
immediate-release opioids. |
metoprolol succinate |
AstraZeneca |
019962 |
SE2 |
027 |
S |
4/30/2004 |
2/15/2005 |
9.6 |
Provides for the broadening of the initial starting dose in hypertension
of metoprolol succinate ER from the current 50 to 100 mg approved dose
to 25 mg to 100 mg dose range. |
candesartan cilexetil |
AstraZeneca |
020838 |
SE1 |
024 |
P |
6/30/2004 |
2/22/2005 |
7.8 |
Provides for the use of Atacand® (candesartan cilexetil) 4, 8, 16, and
32 mg Tablets for the treatment of heart failure (NYHA class II-IV and
ejection fraction
≤40%) to reduce the risk of death from cardiovascular causes and to
reduce hospitalizations for heart failure. |
ribavirin |
Roche |
021511 |
SE1 |
005 |
P |
8/26/2004 |
2/25/2005 |
6.0 |
Provides for the use of Copegus® (ribavirin) 200 mg tablet for the
treatment of chronic hepatitis C in adult patients coinfected with human immunodeficiency virus (HIV) in combination with Pegasys® (peginterferon
alfa-2a). |
rosiglitazone |
GlaxoSmithKline |
021071 |
SE1 |
012 |
S |
4/30/2004 |
2/28/2005 |
10.0 |
Provides for the use of Avandia 8 mg per day (a new higher strength) in
combination with a sulfonylurea to treat patients with type 2 diabetes
mellitus and for the use of Avandia 4 mg and 8 mg per day in combination
with a sulfonylurea and metformin (triple therapy). |
aripiprazole |
Otsuka |
021436 |
SE1 |
005 |
S |
1/30/2004 |
3/1/2005 |
13.0 |
Provides for the use of Abilify® Tablets as maintenance
therapy in Bipolar I Disorder |
aripiprazole |
Otsuka |
021713 |
SE1 |
003 |
S |
2/16/2005 |
3/1/2005 |
0.4 |
Provides for the use of Abilify® Oral Solution as maintenance
therapy in Bipolar I Disorder |
sirolimus |
Wyeth |
021083 |
SE5 |
019 |
P |
9/13/2004 |
3/11/2005 |
5.9 |
Provides for the addition of pediatric pharmacokinetics
information to the labeling along with results of a clinical study in
pediatric patients <18 years of age at high immunologic risk for acute
rejection (oral solution). |
sirolimus |
Wyeth |
021110 |
SE5 |
024 |
P |
9/13/2004 |
3/11/2005 |
5.9 |
Provides for the addition of
pediatric pharmacokinetics information to the labeling along with results
of a clinical study in pediatric patients <18 years of age at high
immunologic risk for acute rejection (tablets). |
temozolomide |
Schering |
021029 |
SE1 |
008 |
P, O |
9/15/2004 |
3/15/2005 |
6.0 |
Provides clinical support for the use of Temodar Capsules
for the treatment of patients with newly diagnosed high grade gliomas
concomitantly with radiotherapy and then as adjuvant treatment. |
micafungin sodium |
Fujisawa Healthcare |
021754 |
N |
000 |
S |
4/26/2004 |
3/16/2005 |
10.7 |
Provides for the use of Mycamine™ (micafungin sodium) for
Injection, for the treatment of esophageal candidiasis. |
ibandronate sodium |
Roche |
021455 |
SE2 |
001 |
S |
5/25/2004 |
3/24/2005 |
10.0 |
Provides for once-monthly treatment of postmenopausal
osteoporosis with Boniva (ibandronate sodium) 150 mg Tablets. |
bortezomib |
Millennium |
021602 |
SE1 |
006 |
P, O |
9/28/2004 |
3/25/2005 |
5.9 |
Provides for the use of Velcade (bortezomib) for Injection
for treatment of multiple myeloma patients who have received as least one
prior therapy. |
ondansetron |
GlaxoSmithKline |
020007 |
SE5 |
035 |
P |
9/29/2004 |
3/25/2005 |
5.8 |
Provides for updating the label with
new pediatric information. |
budesonide |
AstraZeneca |
021324 |
SE1 |
005 |
S |
7/1/2004 |
4/29/2005 |
9.9 |
Provides for the use of Entocort EC (budesonide) Capsules,
3 mg for the maintenance of clinical remission of mild to moderate
Crohn’s disease involving the ileum and/or the ascending colon for up to
3 months. |
lopinavir;
ritonavir |
Abbott |
021226 |
SE2 |
016 |
S |
7/1/2004 |
4/29/2005 |
9.9 |
Provides for the use of Kaletra 800/200mg once-daily
administration for the treatment of HIV- infection in therapy-naïve
adult patients. |
carvedilol |
GlaxoSmithKline |
020297 |
SE1 |
013 |
S |
1/20/2004 |
4/29/2005 |
15.3 |
Provides for the revision of the package insert to include
the results of
the COMET trial for Coreg (carvedilol) 3.125, 6.25, 12.5 and 25 mg
Tablets. |
ropinirole hydrochloride |
GlaxoSmithKline |
020658 |
SE1 |
013 |
P |
7/7/2003 |
5/4/2005 |
22.1 |
Provides for the use of Requip (ropinirole HCl) Tablets for
Restless Legs Syndrome (RLS). |
azelaic
acid |
Berlex |
021470 |
SE1 |
003 |
S |
12/18/2003 |
5/5/2005 |
16.6 |
Provides for a qualified reduction of erythema during the
topical treatment of inflammatory papules and pustules of mild to
moderate rosacea. |
abacavir
sulfate; lamivudine; zidovudine |
GlaxoSmithKline |
021205 |
SE7 |
011 |
S |
7/16/2004 |
5/13/2005 |
9.9 |
Provides for the use of Trizivir Tablets in combination with other
antiretroviral agents or alone for the treatment of HIV-1 infection. |
ethinyl
estradiol; norgestimate |
Ortho-McNeil |
021690 |
N |
000 |
P |
11/19/2004 |
5/13/2005 |
19.6 |
Provides for revision to the Pediatric Use subsection of
the PRECAUTIONS
section of the prescribing information for Ortho TriCyclen to
incorporate the results from the CAPPS-169 study entitled “The Effect of
Ortho TriCyclen on Bone Mineral Density in Pediatric Subjects with
Anorexia Nervosa”. |
ertapenem
sodium |
Merck |
021337 |
SE1 |
018 |
P |
11/22/2004 |
5/18/2005 |
5.8 |
Provides for the use of Invanz (ertapenem for injection) in
the pediatric population. |
candesartan cilexetil |
AstraZeneca |
020838 |
SE1 |
022 |
P |
3/18/2005 |
5/18/2005 |
10.6 |
Provides for the use of Atacand (candesartan cilexetil) 4,
8, 16, and 32 mg Tablets for the treatment of heart failure (NYHA class
II-IV) in patients with left
ventricular systolic dysfunction (ejection fraction <40%) to reduce
cardiovascular death and to reduce
heart failure hospitalizations. Atacand also has an added effect on
these outcomes when used with an ACE inhibitor. |
sodium
iodide I-131 |
Draximage |
021305 |
SE1 |
003 |
S |
7/19/2004 |
5/19/2005 |
10.0 |
Provides for the use of Sodium Iodide I 131 Capsules USP
(diagnostic oral) in performance of the radioactive iodide (RAI) uptake
test to evaluate thyroid function. Diagnostic doses may also be employed
in localizing metastases associated with thyroid malignancies. |
meropenem |
AstraZeneca |
050706 |
SE1 |
018 |
S |
7/28/2004 |
5/25/2005 |
9.9 |
Provides for the use of meropenem, 500 mg IV every 8 hours,
as treatment for patients with complicated skin and skin structure
infections (cSSSI) due to
Staphylococcus aureus (methicillin susceptible strains), Streptococcus
pyogenes, Streptococcus agalactiae, viridans group streptococci,
Enterococcus faecalis, Pseudomonas aeruginosa, Escherichia coli, Proteus
mirabilis, Bacteroides fragilis, and Peptostreptococcus species. |
fondaparinux sodium |
GlaxoSmithKline |
021345 |
SE1 |
010 |
S |
7/30/2004 |
5/26/2005 |
9.9 |
Provides for the use of Arixtra (fondaparinux sodium,
injection) in patients undergoing abdominal surgery who are at risk for
thromboembolic complications. |
pregabalin |
Pfizer |
021724 |
N |
000 |
S |
10/31/2003 |
6/10/2005 |
19.3 |
Provides for the use of Lyrica (pregabalin) 25, 50, 75, and
100, 150, 200,
225, and 300-mg capsules as adjunctive therapy for adult patients with
partial onset seizures. |
moxifloxacin hydrochloride |
Bayer |
021277 |
SE1 |
022 |
S |
8/13/2004 |
6/13/2005 |
10.0 |
Provides for the use of AVELOX® (moxifloxacin hydrochloride
in NaCl injection) I.V. for the treatment of adults (≥ 18 years of age)
with complicated skin and skin structure infections caused by
methicillin susceptible Staphylococcus aureus, Escherichia coli,
Klebsiella pneumoniae, and Enterobacter cloacae. |
moxifloxacin hydrochloride |
Bayer |
021085 |
SE1 |
026 |
S |
8/13/2004 |
6/13/2005 |
10.0 |
Provides for the use of AVELOX® (moxifloxacin
hydrochloride) Tablets for the treatment of adults (≥ 18 years of age)
with complicated skin and skin structure infections caused by
methicillin susceptible Staphylococcus aureus, Escherichia coli,
Klebsiella pneumoniae, and Enterobacter cloacae. |
bivalirudin |
Medicines Company |
020873 |
SE1 |
006 |
S |
7/28/2003 |
6/13/2005 |
22.6 |
Provides for the use of Angiomax® (bivalirudin) for
Injection with provisional use of glycoprotein IIb/IIIa inhibitor (GPI)
as listed in the CLINICAL
TRIALS REPLACE-2 section for use as an anticoagulant in patients
undergoing percutaneous coronary intervention (PCI). |
capecitabine |
Hoffmann-La Roche |
020896 |
SE1 |
016 |
S |
8/18/2004 |
6/15/2005 |
9.9 |
Provides for the use of XELODA (Capcitabine) oral tablets
as a single agent for adjuvant treatment in patients with Dukes’ C colon
cancer who have undergone complete resection of the primary tumor when
treatment with fluoropyrimidine therapy alone is preferred. |
nitazoxanide |
Romark |
021818 |
N |
000 |
P |
5/29/2002 |
6/16/2005 |
36.6 |
Provides for the use Alinia® (nitazoxanide) Tablets for the
treatment of diarrhea caused by Cryptosporidium parvum in non-HIV
infected patients 12 years of age and older. |
nitazoxanide |
Romark |
021498 |
SE5 |
003 |
P |
12/20/2004 |
6/16/2005 |
5.9 |
Provides for the use of Alinia®
(nitazoxanide) for Oral Suspension for the treatment of diarrhea caused
by Cryptosporidium parvum in non-HIV infected patients 12 years of age
and older. |
iron
sucrose |
Luitpold |
021135 |
SE1 |
008 |
S |
8/18/2003 |
6/17/2005 |
22.0 |
Provides for the use of Venofer® (Iron Sucrose Injection,
USP) for the treatment of iron deficiency anemia in the following
patients:
• non-dialysis dependent chronic kidney disease (NDD-CKD) patients
receiving an erythropoietin
• non-dialysis dependent chronic kidney disease (NDD-CKD) patients not
receiving an erythropoietin. |
levetiracetam |
UCB
|
021505 |
SE5 |
007 |
P |
12/21/2004 |
6/21/2005 |
6.0 |
Provides for the use of Keppra (levetiracetam) oral
solution as adjunctive therapy in the treatment of partial onset
seizures in children 4 years of age and older with epilepsy. |
levetiracetam |
UCB
|
021035 |
SE5 |
040 |
P |
12/21/2004 |
6/21/2005 |
6.0 |
Provides for the use of Keppra (levetiracetam) tablets as
adjunctive therapy in the treatment of partial onset seizures in
children 4 years of age and older with epilepsy. |
somatropin |
Genentech |
019676 |
SE1 |
020 |
S |
12/22/2003 |
6/28/2005 |
18.2 |
Provides for the long-term treatment of idiopathic short
stature. |
somatropin |
Genentech |
020522 |
SE1 |
021 |
S |
2/2/2004 |
6/28/2005 |
16.8 |
Provides for the long-term treatment of idiopathic short
stature. |
topiramate |
Ortho-McNeil |
020505 |
SE1 |
018 |
S |
10/30/2002 |
6/29/2005 |
32.0 |
Provides for the use of Topamax (topiramate) Tablets as initial monotherapy
in patients 10 years of age and older with partial onset or primary
generalized tonic-clonic seizures. |
topiramate |
Ortho-McNeil |
020844 |
SE1 |
015 |
S |
10/30/2002 |
6/29/2005 |
32.0 |
Provides for the use of Topamax (topiramate) Sprinkle
Capsules as initial monotherapy
in patients 10 years of age and older with partial onset or primary
generalized tonic-clonic seizures. |
mixed
salts of a single-entity amphetamine |
Shire |
021303 |
SE5 |
009 |
P |
9/17/2004 |
7/21/2005 |
10.1 |
Provides for the use of Adderall XR in the treatment of
adolescents with attention-deficit hyperactivity disorder. |
montelukast sodium |
Merck |
021409 |
SE1 |
012 |
S |
9/30/2004 |
7/27/2005 |
9.9 |
Provides for the use of Singulair (montelukast sodium) Oral
Granules for the relief of symptoms of perennial allergic rhinitis (PAR)
in adults and pediatric patients 6 months of age and older. |
montelukast sodium |
Merck |
020830 |
SE1 |
035 |
S |
9/30/2004 |
7/27/2005 |
9.9 |
Provides for the use of Singulair (montelukast sodium)
Chewable Tablets for the relief of symptoms of perennial allergic
rhinitis (PAR) in adults and pediatric patients 6 months of age and
older. |
montelukast sodium |
Merck |
020829 |
SE1 |
033 |
S |
9/30/2004 |
7/27/2005 |
9.9 |
Provides for the use of Singulair (montelukast sodium)
Tablets for the relief of symptoms of perennial allergic rhinitis (PAR)
in adults and pediatric patients 6 months of age and older. |
rosiglitazone |
GlaxoSmithKline |
021071 |
SE5 |
015 |
P |
9/30/2004 |
7/29/2005 |
9.9 |
Provides for changes to the labeling describing the
results of a study comparing the effects of Avandia to those of metformin
in children with type 2 diabetes mellitus, aged 10-17 years. An indication
for the use of Avandia in this population is not supported by the results
of the study. |
celecoxib |
Pfizer |
020998 |
SE1 |
018 |
S |
10/1/2004 |
7/29/2005 |
9.9 |
Provides for the use of Celebrex® (celecoxib) capsules for
the relief of signs and symptoms of ankylosing spondylitis. |
valsartan |
Novartis |
021283 |
SE1 |
011 |
S |
12/17/2003 |
8/3/2005 |
19.6 |
Provides for the use of Diovan (valsartan) 40, 80, 160, and
320 mg Tablets in the treatment of patients post-myocardial infarction.
In clinically stable patients with left ventricular failure or left
ventricular dysfunction following myocardial infarction, Diovan is
indicated to reduce cardiovascular mortality. |
levofloxacin |
Ortho McNeil |
021721 |
SE2 |
002 |
S |
11/2/2004 |
8/4/2005 |
9.0 |
Provides for the use of Levaquin® (levofloxacin) 750 mg
Oral Solution once daily for five days for the treatment of acute
bacterial sinusitis. |
levofloxacin |
Ortho McNeil |
020635 |
SE2 |
038 |
S |
11/2/2004 |
8/4/2005 |
9.0 |
Provides for the use of Levaquin® (levofloxacin or
levofloxacin in 5% dextrose) Injection once daily for five days for the
treatment of acute bacterial sinusitis. |
levofloxacin |
Ortho McNeil |
020634 |
SE2 |
037 |
S |
11/2/2004 |
8/4/2005 |
9.0 |
Provides for the use of Levaquin® (levofloxacin) Tablets
once daily for five days for the treatment of acute bacterial sinusitis. |
meloxicam |
Boehringer Ingelheim |
021530 |
SE1 |
001 |
P, O |
2/18/2005 |
8/11/2005 |
5.7 |
Provides for the use of Mobic Oral Suspension for relief of
the signs and symptoms of pauciarticular or polyarticular course
Juvenile Rheumatoid Arthritis in patients 2 years of age and older. |
meloxicam |
Boehringer Ingelheim |
020938 |
SE1 |
013 |
P, O |
2/18/2005 |
8/11/2005 |
5.7 |
Provides for the use of Mobic Tablets for relief of the
signs and symptoms of pauciarticular or polyarticular course Juvenile
Rheumatoid Arthritis in patients 2 years of age and older. |
fludeoxyglucose F18 |
North Shore/LIJ Research Institute |
021870 |
N |
000 |
S |
11/19/2004 |
8/19/2005 |
9.0 |
Provides for the use of Fludeoxyglucose F 18 Injection: 1.
In positron emission tomography (PET) imaging for assessment of abnormal
glucose
metabolism to assist in the evaluation of malignancy in patients with
known or suspected abnormalities found by other testing modalities, or
in patients with an existing diagnosis of cancer. 2. In positron
emission tomography (PET) imaging in patients with coronary artery
disease and left ventricular dysfunction, when used together with
myocardial perfusion imaging, for the identification of left ventricular
myocardium with residual glucose metabolism and
reversible loss of systolic function. 3. In positron emission
tomography (PET) imaging in patients for the identification of regions
of abnormal glucose metabolism associated with foci of epileptic
seizures. |
perindopril erbumine |
Solvay |
020184 |
SE1 |
011 |
P |
12/10/2004 |
8/23/2005 |
8.4 |
Provides for the use of Aceon® 2, 4 and 8 mg Tablets in
patients with stable coronary artery disease to reduce the risk of
cardiovascular mortality or non-fatal myocardial infarction. |
iloprost |
CoTherix |
021779 |
SE1 |
001 |
S |
4/27/2005 |
8/24/2005 |
3.9 |
Provides inclusion of the results of “A Placebo-Controlled
Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation
Solution as Add-On Therapy
with Bosentan in Subjects with Pulmonary Arterial Hypertension”. |
insulin
aspart |
Novo
Nordisk |
020986 |
SE5 |
033 |
P |
3/15/2005 |
9/13/2005 |
6.0 |
Provides for revision to the Pediatric Use subsection of
the PRECAUTIONS section of the package insert for the use of NovoLog in
patients 6 through 18 years old. |
anastrozole |
AstraZeneca |
020541 |
SE7 |
016 |
S |
11/18/2004 |
9/16/2005 |
9.9 |
Provides the updated report of the ATAC data as requested
in a subpart H commitment associated with the approval of supplemental
application 010. |
atorvastatin calcium |
Pfizer |
020702 |
SE1 |
042 |
S |
12/20/2004 |
9/21/2005 |
9.0 |
Provides for the use
of atorvastatin in adult patients with type 2 diabetes and without
clinically evident coronary heart disease (but with multiple risk factors
for coronary heart disease such as retinopathy, albuminuria, smoking, or
hypertension), to reduce the risk of myocardial infarction and stroke.
It's also indicated to reduce the risk of stroke in adult patients without
clinically evident coronary heart disease but with multiple risk factors
for coronary heart disease such as age, smoking, hypertension, low HDL-C,
or a family history of early coronary heart disease. The
post-marketing adverse event “fatigue” was added to the ADVERSE REACTIONS
section of the label. |
amlodipine besylate |
Pfizer |
019787 |
SE1 |
038 |
S |
4/1/2005 |
9/28/2005 |
5.9 |
Proposes changes to the package insert for the use of
Norvasc (amlodipine besylate) Tablets in patients with angiographically
documented coronary artery disease. |
exemestane |
Pfizer |
020753 |
SE1 |
006 |
S |
12/9/2004 |
10/5/2005 |
9.9 |
Provides for the use of Aromasin® (exemestane) Tablets, 25
mg for adjuvant treatment of postmenopausal women with estrogen-receptor
positive early breast cancer who have received two to three years of
tamoxifen and are switched to AROMASIN® for completion of a total of
five consecutive years of adjuvant hormonal therapy. |
ritonavir |
Abbott |
020659 |
SE5 |
034 |
P |
4/7/2005 |
10/6/2005 |
6.0 |
Provides for the use of NORVIR (ritonavir) oral solution in
combination with other antiretroviral agents for the treatment of
HIV-infection in pediatric patients from one month to two years of age. |
ritonavir |
Abbott |
020945 |
SE5 |
017 |
P |
4/7/2005 |
10/6/2005 |
6.0 |
Provides for the use of NORVIR (ritonavir) soft gelatin
capsules in combination with other antiretroviral agents for the
treatment of HIV-infection in pediatric patients from one month to two
years of age. |
fexofenadine hydrochloride |
Aventis |
020872 |
SE2 |
015 |
S |
12/14/2004 |
10/13/2005 |
10.0 |
Provides for Allegra (fexofenadine) 180 mg tablets used
once daily in chronic idiopathic urticiaria (CIU). |
ertapenem
sodium |
Merck |
021337 |
SE1 |
019 |
S |
12/17/2004 |
10/14/2005 |
9.9 |
Provides for the use of INVANZ® (ertapenem sodium) in the
treatment of adult diabetic foot infections without osteomyelitis. |
iron
sucrose |
Luitpold |
021135 |
SE1 |
013 |
S |
12/17/2004 |
10/17/2005 |
10.0 |
Provides for the use of Venofer (iron sucrose injection,
USP) for treatment of iron deficiency anemia in peritoneal dialysis
dependent-chronic kidney disease (PDD-CKD) patients receiving an
erythropoietin. |
insulin
detemir (rDNA origin) |
Novo
Nordisk |
021878 |
N |
000 |
S |
12/20/2004 |
10/19/2005 |
10.0 |
Provides for the use of Levemir (insulin detemir) in
pediatric patients with type 1 diabetes. |
losartan
potassium; hydrochlorothiazide |
Merck |
020387 |
SE2 |
037 |
S |
12/20/2004 |
10/20/2005 |
10.0 |
Provides for registration of a losartan 100 mg and
hydrochlorothiazide
12.5 mg fixed-dose combination tablet. |
insulin (rDNA
origin) |
Novo
Nordisk |
019938 |
SE3 |
048 |
S |
12/23/2004 |
10/21/2005 |
9.9 |
Provides for label revisions to include the intravenous
administration of Novolin R (regular, human insulin [rDNA origin]
injection) under proper medical supervision in a clinical setting for
the treatment of patients with diabetes mellitus. |
insulin
aspart |
Novo
Nordisk |
020986 |
SE3 |
032 |
S |
12/23/2004 |
10/21/2005 |
9.9 |
Provides for label revisions to include the intravenous
administration of NovoLog (insulin aspart [rDNA origin] injection) under
proper medical supervision in a clinical setting for the
treatment of patients with diabetes mellitus. |
oxcarbazepine |
Novartis |
021285 |
SE5 |
008 |
P |
12/14/2004 |
10/28/2005 |
10.5 |
Provides for the use of Trileptal (oxcarbazepine) oral
solution for use as adjunctive therapy in the treatment of partial
seizures in children with epilepsy aged two to four years. |
oxcarbazepine |
Novartis |
021014 |
SE5 |
013 |
P |
12/14/2004 |
10/28/2005 |
10.5 |
Provides for the use of Trileptal (oxcarbazepine) tablets
for use as adjunctive therapy in the treatment of partial seizures in
children with epilepsy aged two to four years. |
aprepitant |
Merck |
021549 |
SE1 |
008 |
S |
9/29/2004 |
10/28/2005 |
13.0 |
Provides for the use of Emend (aprepitant) in the
prevention of nausea and vomiting associated with initial and repeat
courses of moderately emetogenic cancer chemotherapy. |
erlotinib
hydrochloride |
OSI |
021743 |
SE1 |
003 |
P |
5/2/2005 |
11/2/2005 |
6.0 |
Provides for the use of Tarceva (erlotinib) tablets in
combination with gemcitabine for the first-line treatment of patients
with locally advanced,
unresectable or metastatic pancreatic cancer. |
fluocinolone acetonide |
Hill
Dermac |
021930 |
N |
000 |
P |
5/9/2005 |
11/9/2005 |
6.0 |
Provides for the use of fluocinolone acetonide oil, 0.01%
ear drops for
treatment of chronic eczematous external otitis. |
venlafaxine hydrochloride |
Wyeth |
020699 |
SE1 |
054 |
S |
9/29/2004 |
11/18/2005 |
13.6 |
Provides for the use of Effexor XR in the treatment of
short-term panic disorder. |
venlafaxine hydrochloride |
Wyeth |
020699 |
SE1 |
057 |
S |
9/29/2004 |
11/18/2005 |
13.6 |
Provides for the use of Effexor XR in the treatment of
long-term panic disorder. |
sodium
oxybate |
Orphan Medical |
021196 |
SE1 |
005 |
S |
1/18/2005 |
11/18/2005 |
10.0 |
Provides for the use of Xyrem ® (sodium oxybate) oral
solution for the treatment of excessive daytime sleepiness in patients
with narcolepsy. |
moxifloxacin hydrochloride |
Bayer |
021085 |
SE1 |
027 |
S |
2/1/2005 |
11/22/2005 |
9.7 |
Provides for a change in the product labeling to include
the use of Avelox® (moxifloxacin hydrochloride) Tablets for the
treatment of complicated intra-abdominal infections caused by specified
bacteria. |
moxifloxacin hydrochloride |
Bayer |
021277 |
SE1 |
024 |
S |
1/31/2005 |
11/22/2005 |
9.7 |
Provides for a change in the product labeling to include
the use of Avelox® (moxifloxacin hydrochloride in NaCl injection) I.V.
for the treatment of complicated intra-abdominal infections caused by
specified bacteria. |
glimepiride |
Aventis |
020496 |
SE5 |
015 |
P |
3/15/2005 |
11/28/2005 |
8.5 |
Provides for changes to the following sections of the
Amaryl (glimepiride) Tablets package insert: CLINICAL
PHARMACOLOGY-Special Populations-Pediatric; PRECAUTIONS-Pediatric Use;
Adverse Reactions-Pediatric patients |
bivalirudin |
Medicines Company |
020873 |
SE1 |
011 |
S |
1/31/2005 |
11/30/2005 |
10.0 |
Provides for the use of Angiomax® (bivalirudin) for
Injection for patients with, or at risk of, HIT/HITTS undergoing PCI. |
venlafaxine hydrochloride |
Wyeth |
020699 |
SE5 |
059 |
S |
12/2/2004 |
12/1/2005 |
12.0 |
Provides for additional safety data for changes in weight,
height, and appetite occurring in pediatric patients with social anxiety
disorder treated with Effexor XR. |
divalproex sodium |
Abbott |
021168 |
SE1 |
012 |
S |
10/26/2004 |
12/6/2005 |
13.3 |
Proposes the use of Depakote ER as monotherapy in the
treatment of acute
manic or mixed episodes associated with bipolar I disorder, with or
without psychotic features. |
sibutramine hydrocholoride |
Abbott |
020632 |
SE5 |
021 |
P |
6/22/2004 |
12/8/2005 |
17.6 |
Provides for labeling changes to the Meridia (sibutramine
hydrochloride monohydrate) Capsules Package Insert (PI). |
oseltamivir phosphate |
Roche |
021087 |
SE5 |
030 |
S |
4/18/2005 |
12/21/2005 |
8.1 |
Provides for the use of Tamiflu (oseltamivir phosphate)
Capsules for prophylaxis of influenza for patients between 1-12 years of
age. |
oseltamivir phosphate |
Roche |
021246 |
SE5 |
017 |
S |
4/18/2005 |
12/21/2005 |
8.1 |
Provides for the use of Tamiflu (oseltamivir phosphate)
Oral Suspension for prophylaxis of influenza for patients between 1-12
years of age. |
alendronate sodium |
Merck |
020560 |
SE1 |
038 |
P |
11/3/2004 |
12/21/2005 |
34.7 |
Provides for information in the Clinical
Pharmacology and ADVERSE REACTIONS sections concerning an osteogenesis
imperfecta study, and update the Precautions section with the statement
that FOSAMAX is not indicated for use in children. |
estradiol;
levonorgestrel |
Berlex |
021885 |
N |
000 |
S |
3/1/2005 |
12/27/2005 |
9.9 |
Provides for the use of Climara Pro (estradiol/levonorgestrel)
Transdermal
System for the prevention of postmenopausal osteoporosis. |
letrozole |
Novartis |
020726 |
SE1 |
012 |
P |
6/28/2005 |
12/28/2005 |
6.0 |
Provides for the use of Femara® (letrozole tablets) for the
adjuvant treatment of postmenopausal women with hormone receptor
positive early breast cancer. |