Established Name |
Applicant |
NDA
Number |
Supp
Type |
Supp
Number |
Priority
Review |
Receipt
Date |
Approval
Date |
Total Approval Time (Months) |
Indication / Description |
sunitinib |
Pfizer |
021968 |
N |
000 |
Y |
8/11/2005 |
1/26/2006 |
5.5 |
Provides for the treatment of advanced renal cell carcinoma. |
bromfenac
sodium |
ISTA |
021664 |
SE1 |
001 |
|
7/18/2005 |
1/27/2006 |
6.3 |
Provides for the use of Xibrom (bromfenac ophthalmic solution) 0.09% for
the treatment of postoperative inflammation and reduction of ocular pain
in patients who have undergone cataract extraction. |
sumatriptan succinate |
GlaxoSmithKline |
020080 |
SE2 |
036 |
|
4/8/2005 |
2/1/2006 |
9.8 |
Provides for the use of Imitrex (sumatriptan) STATdose 4mg
for the acute treatment of migraine headache. |
albuterol
sulfate |
Ivax |
021457 |
SE1 |
003 |
|
4/12/2005 |
2/3/2006 |
9.8 |
Provides for the use of ProAir HFA (albuterol sulfate) Inhalation
Aerosol for the prevention of exercise-induced bronchospasm in
adolescents and adults 12 years of age and older. |
azelastine hydrochloride |
Medpointe |
020114 |
SE2 |
014 |
|
4/18/2005 |
2/17/2006 |
10.0 |
Provides for a new dosing regimen of one spray twice daily in Seasonal
Allergic Rhinitis patients 12 years of age and older. |
anidulafungin |
Vicuron |
021948 |
N |
000 |
Y |
8/18/2005 |
2/17/2006 |
6.0 |
Provides for the use of Eraxis (anidulafungin) for Injection for the
treatment of patients with candidemia and other forms of Candida
infections (intra-abdominal abscess and peritonitis) |
selegiline |
Somerset |
021708 |
N |
000 |
|
10/16/2003 |
2/27/2006 |
28.4 |
Provides for the use of EMSAM (selegiline transdermal system) patches,
6mg/24 hours, 9mg/24 hours, and 12mg/24 hours in the longer-term
treatment of major depressive disorder in adult patients. |
fluticasone propionate |
GlaxoSmithKline |
021433 |
SE5 |
004 |
|
4/29/2005 |
2/28/2006 |
10.0 |
Provides for the use Flovent HFA Inhalation Aerosol for the maintenance
treatment of asthma as prophylactic therapy in patients 4 through 11
years of age. |
fluocinonide |
Medicis |
021758 |
SE1 |
001 |
|
5/2/2005 |
3/2/2006 |
10.0 |
Provides for the use of Vanos™ (fluocinonide) Cream, 0.1%,
as a corticosteroid indicated for relief of the inflammatory and
pruritic manifestations of corticosteroid
responsive dermatoses in patients 12 years of age or older. |
emtricitabine; tenofovir disoproxil fumarate |
Gilead Sciences |
021752 |
SE7 |
005 |
|
5/9/2005 |
3/8/2006 |
10.0 |
Provides for the use of TRUVADA (emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg) Tablets for use in combination with other
antiretroviral agents (such as non-nucleoside reverse transcriptase
inhibitors or protease inhibitors) for the treatment of HIV-1 infection
in adults. |
tenofovir
disoproxil fumarate |
Gilead Sciences |
021356 |
SE7 |
016 |
|
5/9/2005 |
3/8//2006 |
10.0 |
Provides for the use of VIREAD (tenofovir disoproxil fumarate) 300 mg
Capsules in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults. |
ibuprofen |
Banner |
021472 |
SE1 |
005 |
|
1/27/2005 |
3/13/2006 |
13.5 |
Provides for ibuprofen capsules, 200 mg, for the treatment of migraine. |
simvastatin; ezetimibe |
MSP
Singapore |
021687 |
SE4 |
006 |
|
5/17/2005 |
3/16/2006 |
10.0 |
Provides for changes to the CLINICAL STUDIES, Primary
Hypercholesterolemia,
Vytorin subsection of the package insert to add efficacy data for the
ezetimibe/simvastatin combination
product and for an atorvastatin product on LDL-C and other lipid
parameters in patients with hypercholesterolemia. |
treprostinil sodium |
United Therapeutics |
021272 |
SE7 |
005 |
Y |
10/13/2005 |
3/20/2006 |
5.2 |
Provides information to the labeling on the use of Remodulin Injection (treprostinil
sodium) 1.0, 2.5, 5.0, and 10 mg/ml for the treatment of patients with
pulmonary arterial hypertension (PAH) requiring transition from Flolan®. |
docetaxel |
Sanofi-Aventis |
020449 |
SE1 |
035 |
Y |
9/26/2005 |
3/22/2006 |
5.8 |
Provides for the use of Taxotere® (docetaxel) Injection Concentrate in
combination with cisplatin and fluorouracil for the treatment of
patients with advanced gastric adenocarcinoma, including adenocarcinoma
of the gastroesophageal junction, who have not
received prior chemotherapy for advanced disease. |
zanamivir |
GlaxoSmithKline |
021036 |
SE1 |
008 |
Y |
11/4/2005 |
3/29/2006 |
4.8 |
Provides for the use of RELENZA® (zanamivir for inhalation) for
prophylaxis of influenza in adults and children five years of age and
older. |
zanamivir |
GlaxoSmithKline |
021036 |
SE1 |
009 |
Y |
11/4/2005 |
3/29/2006 |
4.8 |
Provides for the use of RELENZA® (zanamivir for inhalation) for
prophylaxis of influenza in adults and children five years of age and
older. |
tacrolimus |
Astellas |
050708 |
SE1 |
024 |
|
6/2/2005 |
3/29/2006 |
9.9 |
Provides for the use of Prograf® (tacrolimus) Capsules for the
prophylaxis of organ rejection in patients receiving allogeneic heart
transplants. |
tacrolimus |
Astellas |
050709 |
SE1 |
019 |
|
6/2/2005 |
3/29/2006 |
9.9 |
Provides for the use of Prograf® (tacrolimus) Injection for the
prophylaxis of organ rejection in patients receiving allogeneic heart
transplants. |
fluvastatin sodium |
Novartis |
020261 |
SE5 |
036 |
Y |
10/17/2005 |
4/10/2006 |
5.8 |
Provides for the addition of an indication for the treatment of
heterozygous familial hypercholesterolemia in adolescent boys and
postmenarchal girls, ages 10 to 16 years, with a recommended dosing
range of Lescol capsules 20 to 40 mg twice daily. |
fluvastatin sodium |
Novartis |
020261 |
SE2 |
035 |
|
6/16/2005 |
4/10/2006 |
9.8 |
Provides for the addition of an indication for the treatment of
heterozygous familial hypercholesterolemia in adolescent boys and
postmenarchal girls, ages 10 to 16 years, with a recommended dosing
range of Lescol capsules 20 to 40 mg twice daily. |
fluvastatin sodium |
Novartis |
021192 |
SE5 |
011 |
Y |
10/17/2005 |
4/10/2006 |
5.8 |
Provide for the addition of an indication for the treatment of
heterozygous familial hypercholesterolemia in adolescent boys and
postmenarchal girls, ages 10 to 16 years, with a recommended dosing
range of Lescol XL 80 mg tablet once daily. |
fluvastatin sodium |
Novartis |
021192 |
SE2 |
010 |
|
6/16/2005 |
4/10/2006 |
9.8 |
Provide for the addition of an indication for the treatment of
heterozygous familial hypercholesterolemia in adolescent boys and
postmenarchal girls, ages 10 to 16 years, with a recommended dosing
range of Lescol XL 80 mg tablet once daily. |
amlodipine besylate; benazepril hydrochloride |
Novartis |
020364 |
SE2 |
023 |
|
12/23/2002 |
4/11/2006 |
39.6 |
Provides for two higher strengths, 5/40 and 10/40 mg, of Lotrel (amlodipine
besylate and benazepril HCL) Capsules for the treatment of hypertension. |
somatropin (rDNA origin) |
Pfizer |
020280 |
SE1 |
049 |
|
6/28/2005 |
4/27/2006 |
10.0 |
Provides for the use of Genotropin® (somatropin [rDNA origin] for
injection) as long-term treatment of growth failure associated with
Turner Syndrome in patients who have open epiphyses. |
esomeprazole magnesium |
AstraZeneca |
021153 |
SE5 |
022 |
Y |
10/28/2005 |
4/28/2006 |
6.0 |
Provides for the use of the revision of the Pediatric section of the
package insert to add information regarding the use of Nexium®
Delayed-Release Capsules in adolescent patients, 12-17 years of age,
inclusive, for the short term treatment of gastroesophageal reflux
disease (GERD). |
valsartan;
hydrochlorothiazide |
Novartis |
020818 |
SE2 |
027 |
|
6/30/2005 |
4/28/2006 |
9.9 |
Provides for the addition of two new dose strengths (320/12.5 and 320/25
mg) of Diovan HCT (valsartan hydrochlorothiazide) Tablets for the
treatment of hypertension. |
octreotide actetate |
Novartis |
021008 |
SE5 |
018 |
Y |
11/10/2005 |
5/10/2006 |
6.0 |
Provides the results of a study of the use of Sandostatin LAR Depot in
pediatric patients with hypothalamic obesity. |
rosiglitazone maleate; metformin hydrochloride |
SB
Pharmco |
021410 |
SE1 |
010 |
|
7/1/2005 |
5/19/2006 |
10.6 |
Provides clinical data in support of Avandamet® (rosiglitazone maleate
and metformin HCl) as an adjunct to diet and exercise to improve
glycemic control in patients with type 2 diabetes mellitus when
treatment with dual rosiglitazone
and metformin therapy is appropriate. |
ezetimibe |
MSP
Singapore |
021445 |
SE1 |
013 |
|
7/27/2005 |
5/23/2006 |
9.9 |
Provides for a new indication for Zetia to be administered in
combination with fenofibrate, as adjunctive therapy to diet for the
reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients
with mixed hyperlipidemia. |
thalidomide |
Celgene |
021430 |
N |
000 |
|
12/23/2003 |
5/25/2006 |
29.1 |
Provides for the use of Thalomid® (thalidomide) capsules, 50 mg, 100
mg, and 200 mg for the treatment of patients with newly diagnosed
multiple myeloma. |
daptomycin |
Cubist |
021572 |
SE1 |
008 |
Y |
9/26/2005 |
5/25/2006 |
7.9 |
Provides for the use of CUBICIN® (daptomycin for injection) Intravenous,
500 mg/vial, for the treatment of Staphylococcus aureus bloodstream
infections (bacteremia), including those with right-sided infective
endocarditis, caused by methicillin-susceptible
and methicillin-resistant isolates. |
bupropion
hydrochloride extended-release |
GlaxoSmithKline |
021515 |
SE1 |
010 |
Y |
11/24/2004 |
6/12/2006 |
18.6 |
Provides for the use of Wellbutrin XL in the prevention of seasonal
major depressive episodes in patients with
seasonal affective disorder. |
topotecan
hydrochloride |
GlaxoSmithKline |
020671 |
SE1 |
014 |
Y |
12/15/2005 |
6/14/2006 |
6.0 |
Provides for the use of HYCAMTIN® (topotecan hydrochloride) for
Injection 4 mg in combination with cisplatin for the treatment of Stage
IV-B, recurrent, or persistent carcinoma of the cervix which is not
amenable to curative treatment with surgery and/or radiation therapy. |
bimatoprost |
Allergan |
021275 |
SE1 |
013 |
|
7/2/2003 |
6/22/2006 |
35.7 |
Provides for the use of Lumigan (bimatoprost ophthalmic solution) 0.03%
for the reduction of elevated intraocular pressure in patients with open
angle glaucoma or ocular hypertension. |
rivastigmine tartrate |
Novartis |
021025 |
SE1 |
008 |
|
2/13/2006 |
6/27/2006 |
4.4 |
Provides for the use of Exelon oral solution in the treatment of mild to
moderate dementia associated with Parkinson’s Disease. |
rivastigmine tartrate |
Novartis |
020823 |
SE1 |
016 |
|
9/1/2005 |
6/27/2006 |
9.8 |
Provides for the use of Exelon capsules in the treatment of mild to
moderate dementia associated with Parkinson’s Disease. |
dasatinib |
Bristol-Myers Squibb |
022072 |
N |
000 |
Y |
12/28/2005 |
6/28/2006 |
6.0 |
Provides for the use of SPRYCEL (dasatinib) Tablets for the treatment of
adults with Philadelphia chromosome-positive acute lymphoblastic
leukemia with resistance or intolerance to prior therapy. |
lenalidomide |
Celgene |
021880 |
SE1 |
001 |
Y |
12/30/2005 |
6/29/2006 |
6.0 |
Provides for the use of Revlimid® 15 mg and 25 mg capsules in
combination with dexamethasone for the treatment of multiple myeloma
patients who have received at least one prior therapy. |
aprepitant |
Merck |
021549 |
SE1 |
010 |
|
8/30/2005 |
6/30/2006 |
10.0 |
Provides for the use of Emend™ (aprepitant) Capsules for the
prevention of post-operative nausea and vomiting (PONV) utilizing a new
40 mg strength. |
gemcitabine hydrochloride |
Lilly |
020509 |
SE1 |
039 |
|
6/17/2005 |
7/14/2006 |
12.9 |
Provides for the use of Gemzar in combination with carboplatin for the
treatment of patients with advanced ovarian cancer that has relapsed at
least 6 months after completion of platinum-based therapy. |
famciclovir |
Novartis |
020363 |
SE2 |
027 |
|
10/17/2005 |
7/28/2006 |
9.3 |
Provides for the use of Famvir® (famciclovir) tablets in a new dosing
recommendation for the treatment of recurrent genital herpes in
immunocompetent patients, specifically a reduction in course of therapy
from famciclovir 125 mg bid for 5 days to 1000 mg bid for 1 day. |
famciclovir |
Novartis |
020363 |
SE1 |
028 |
|
11/14/2005 |
7/28/2006 |
8.4 |
Provides for the use of Famvir® (famciclovir) tablets for the treatment
of recurrent herpes labialis (cold sores) in immunocompetant patients
with a single dose of famciclovir 1500 mg. |
ertapenem
sodium |
Merck |
021337 |
SE1 |
021 |
|
11/10/2005 |
8/10/2006 |
9.0 |
Provides for the use of INVANZ® (Ertapenem Sodium) for the
prophylaxis of surgical site infection following elective colorectal
surgery. |
risedronate |
Proctor and Gamble |
020835 |
SE1 |
022 |
|
10/20/2005 |
8/11/2006 |
9.7 |
Provides for the use of Actonel 35 mg once a week for the treatment of
osteoporosis in men. |
levetiracetam |
UCB |
021505 |
SE1 |
009 |
|
10/18/2005 |
8/15/2006 |
9.9 |
Provides for the use of Keppra (levetiracetam) oral solution for
adjunctive therapy of myoclonic seizures in adults and adolescents age
12 and over with juvenile myoclonic epilepsy. |
levetiracetam |
UCB |
021035 |
SE1 |
050 |
|
10/18/2005 |
8/15/2006 |
9.9 |
Provides for the use of Keppra (levetiracetam) tablets for adjunctive
therapy of myoclonic seizures in adults and adolescents age 12 and over
with juvenile myoclonic epilepsy. |
clopidogrel bisulfate |
Sanofi-Aventis |
020839 |
SE1 |
034 |
Y |
11/17/2005 |
8/17/2006 |
9.0 |
Provides for the use of Plavix (clopidogrel bisulfate) 75 mg tablets for
patients with ST-segment elevation acute myocardial infarction. |
levonorgestrel |
Duramed |
021045 |
SE6 |
011 |
|
7/22/2004 |
8/24/2006 |
40.1 |
Provides for Over-the-Counter availability of Plan B® for consumers 18
years and older. Plan B® remains available by prescription only for
women 17 years and younger. |
augmented
betamethasone dipropionate |
Schering |
018741 |
SE5 |
028 |
|
10/31/2005 |
8/28/2006 |
9.9 |
Provides for a Geriatric Use section for Diprolene® (augmented
betamethasone dipropionate) Ointment 0.05%. |
augmented
betamethasone dipropionate |
Schering |
019555 |
SE5 |
026 |
|
10/28/2005 |
8/28/2006 |
10.0 |
Provides for a Geriatric Use section for Diprolene® (augmented
betamethasone dipropionate) AF Cream, 0.05%. |
augmented
betamethasone dipropionate |
Schering |
019716 |
SE5 |
022 |
|
10/28/2005 |
8/28/2006 |
10.0 |
Provides for a Geriatric Use section for Diprolene® (augmented
betamethasone dipropionate) Lotion, 0.05% . |
lamotrigine |
GlaxoSmithKline |
020241 |
SE1 |
027 |
|
2/7/2005 |
9/22/2006 |
19.5 |
Provides for Lamictal tablets for adjunctive treatment of primary
generalized tonic-clonic seizures in adults and pediatric patients. |
lamotrigine |
GlaxoSmithKline |
020764 |
SE1 |
020 |
|
2/7/2005 |
9/22/2006 |
19.5 |
Provides for Lamictal Chewable Dispersable tablets for adjunctive
treatment of primary generalized tonic-clonic seizures in adults and
pediatric patients. |
imatinib
mesylate |
Novartis |
021588 |
SE1 |
016 |
Y |
3/28/2006 |
9/27/2006 |
6.0 |
Provides for the use of Gleevec for newly diagnosed Philadelphia
chromosome positive CML in pediatric patients. |
ezetimibe;
simvastatin |
Merck |
021687 |
SE4 |
011 |
|
12/5/2005 |
10/3/2006 |
9.9 |
Provides for labeling changes to add efficacy data for ezetimibe;
simvastatin product and for a rosuvastatin product on LDL-C and other
lipid parameters in patients with hypercholesterolemia. |
drospirenone; ethinyl estradiol |
Berlex |
021873 |
N |
000 |
|
12/23/2004 |
10/4/2006 |
21.4 |
Provides for YAZ
(drospirenone/ethinyl estradiol) for Oral Contraception and Premenstrual
Dysphoric Disorder. |
risperidone |
Janssen |
020272 |
SE1 |
036 |
Y |
12/19/2003 |
10/6/2006 |
33.6 |
Provides for the use of Risperdal Tablets in treatment of the
irritability associated with autistic disorder. |
risperidone |
Janssen |
020588 |
SE1 |
024 |
Y |
12/19/2003 |
10/6/2006 |
33.6 |
Provides for the use of Risperdal Oral Solution in treatment of the
irritability associated with autistic disorder. |
risperidone |
Janssen |
021444 |
SE1 |
008 |
Y |
12/19/2003 |
10/6/2006 |
33.6 |
Provides for the use of Risperdal M-Tabs in treatment of the
irritability associated with autistic disorder. |
esomeprazole |
AstraZeneca |
021153 |
SE1 |
023 |
|
12/15/2005 |
10/11/2006 |
9.9 |
Provides for the use of NEXIUM®
(esomeprazole magnesium) Delayed-Release Capsules for the treatment of
pathological hypersecretory
conditions including Zollinger-Ellison Syndrome. |
doneprezil hydrochloride |
Eisai |
020690 |
SE1 |
026 |
|
12/16/2005 |
10/13/2006 |
9.9 |
Provides for the use of Aricept Tablets in the treatment of dementia of
the Alzheimer’s type in patients with severe Alzheimer’s Disease. |
doneprezil hydrochloride |
Eisai |
021719 |
SE1 |
001 |
|
9/26/2006 |
10/13/2006 |
0.6 |
Provides for the use of Aricept Oral Solution in the treatment of
dementia of
the Alzheimer’s type in patients with severe Alzheimer’s Disease. |
doneprezil hydrochloride |
Eisai |
021720 |
SE1 |
003 |
|
9/26/2006 |
10/13/2006 |
0.6 |
provide for the use of Aricept Orally Disintegrating Tablets in the
treatment of dementia of the Alzheimer’s type in patients with severe
Alzheimer’s Disease. |
docetaxel |
Sanofi-Aventis |
020449 |
SE1 |
039 |
Y |
4/17/2006 |
10/17/2006 |
6.0 |
Provides for the use of Taxotere (docetaxel) Injection Concentrate in
combination with cisplatin and fluorouracil for the induction treatment
of patients with inoperable locally advanced squamous cell carcinoma of
the head and neck (SCCHN). |
ketotifen
fumarate |
Novartis |
021066 |
SE6 |
011 |
|
12/19/2005 |
10/19/2006 |
10.0 |
Provides for the switch of Zaditor™ (ketotifen fumarate ophthalmic
solution) from prescription only to the to over-the-counter indication
of the temporary
relief of itchy eyes due to pollen, ragweed, grass, animal hair, and
dander. |
imatinib
mesylate |
Novartis |
021588 |
SE1 |
011 |
|
12/19/2005 |
10/19/2006 |
10.0 |
Provides for the treatment of adult dermafibrosarcoma protuberans (DFSP). |
imatinib
mesylate |
Novartis |
021588 |
SE1 |
012 |
|
12/19/2005 |
10/19/2006 |
10.0 |
Provides for the treatment of adult myelodysplastic syndrome/myeloproliferative
diseases (MDS/MPD). |
imatinib
mesylate |
Novartis |
021588 |
SE1 |
013 |
|
12/21/2005 |
10/19/2006 |
9.9 |
Provides for the treatment of adult Ph+ acute lymphoblastic leukemia
(ALL)
monotherapy. |
imatinib
mesylate |
Novartis |
021588 |
SE1 |
014 |
|
3/1/2006 |
10/19/2006 |
7.6 |
Provides for the treatment of adult aggressive systemic mastocytosis (ASM). |
imatinib
mesylate |
Novartis |
021588 |
SE1 |
017 |
|
3/29/2006 |
10/19/2006 |
6.7 |
Provides for the treatment of adult hypereosinophilic syndrome/chronic
eosinophilic leukemia (HES/CEL). |
quetiapine fumarate |
AstraZeneca |
020639 |
SE1 |
026 |
|
12/30/2005 |
10/20/2006 |
9.7 |
Provides labeling in response to FDA's request that all manufacturers of
atypical antipsychotic drug products add a Boxed Warning and a Bolded
Warning section to labeling to advise that elderly patients with
dementia-related psychosis treated with atypical antipsychotic drugs are
at an increased risk of death. |
posaconazole |
Schering |
022027 |
N |
000 |
|
12/22/2005 |
10/20/2006 |
9.9 |
Provides for the use of Noxafil (posaconazole) Oral Suspension for the
treatment of oropharyngeal candidiasis, including oropharyngeal
candidiasis refractory to itraconazole and/or fluconazole. |
rosiglitazone maleate; glimepiride |
GlaxoSmithKline |
021700 |
SE1 |
003 |
|
12/20/2005 |
10/24/2006 |
10.1 |
Provides for additional clinical information for Avandaryl
(rosiglitazone maleate and glimepiride) Tablets in adult patients with
type 2 diabetes mellitus who are
naive to pharmacologic therapy. |
somatropin [rDNA origin] |
Lilly |
019640 |
SE1 |
058 |
|
12/23/2005 |
11/1/2006 |
10.3 |
Provides for treatment of short stature or growth failure in children
with SHOX (short stature homeobox-containing gene) deficiency whose
epiphyses are not closed. |
pramipexole dihydrochloride |
Boehringer Ingelheim |
020667 |
SE1 |
013 |
|
7/28/2005 |
11/7/2006 |
15.4 |
Provides for the use of Mirapex (pramipexole dihydrochloride) Tablets
for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). |
bortezomib |
Millennium |
021602 |
SE1 |
010 |
Y |
6/9/2006 |
12/8/2006 |
6.0 |
Provides for the use of Velcade (bortezomib) for injection for the
treatment of patients with mantle cell lymphoma who have received at
least 1 prior therapy. |
paroxetine mesylate |
JDS |
021299 |
SE1 |
017 |
|
3/13/2006 |
12/9/2006 |
8.9 |
Provides for the use of Pexeva (paroxetine mesylate) Tablets for
Generalized Anxiety Disorder. |
celecoxib |
Pfizer |
020998 |
SE5 |
021 |
Y |
6/22/2006 |
12/15/2006 |
5.8 |
Provides for the use of CELEBREX® (celecoxib) Capsules for the relief of
the signs and symptoms of juvenile rheumatoid arthritis (JRA) in
patients 2 years of age and older. |
desflurane |
Baxter |
020118 |
SE5 |
012 |
Y |
6/26/2006 |
12/15/2006 |
5.7 |
Provides for the inclusion of data for the pediatric population ages
2-16 years. |
balsalazide disodium |
Salix |
020610 |
SE5 |
016 |
Y |
6/20/2006 |
12/20/2006 |
6.0 |
Provides for the treatment of mildly to moderately active ulcerative
colitis in patients 5 years of age and older. Safety and
effectiveness of Colazal beyond 8 weeks in children (ages 5-17 years)
and 12 weeks in adults have not been established. |
emtricitabine |
Gilead Sciences |
021896 |
SE5 |
001 |
Y |
6/29/2006 |
12/22/2006 |
5.8 |
Provides for the inclusion of pharmacokinetic data for children from
birth to three months of age in the label. |
exenatide |
Amylin |
021773 |
SE1 |
002 |
|
2/28/2006 |
12/22/2006 |
9.8 |
Provides for the use of exenatide in patients with type 2 diabetes
mellitus who are using a thiazolidinedione alone or in combination with
metformin but
have not achieved adequate glycemic control. |
estradiol;
norethindrone acetate |
Novo
Nordisk |
020907 |
SE2 |
009 |
|
3/1/2006 |
12/28/2006 |
9.9 |
Provides for the use of Activella® (estradiol/norethindrone acetate)
tablets
0.5 mg/0.1 mg for the treatment of moderate to severe vasomotor symptoms
associated with menopause in women who have a uterus. |
estradiol;
norethindrone acetate |
Novo
Nordisk |
022001 |
N |
000 |
|
3/1/2006 |
12/29/2006 |
10.0 |
Provides for the use of Activella (estradiol/norethindrone acetate)
Tablets, 0.5 mg/0.1 mg for prevention of postmenopausal osteoporosis. |