| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
Indication |
|
N020886 |
Panretin |
Alitretinoin |
Ligand Pharm |
1 |
P, O |
02-Feb-99 |
Panretin is indicated
for the treatment of cutaneous lesions in patients with
AIDS-related Kaposi’s sarcoma. |
|
N020954 |
Busulfex |
Busulfan |
Orphan Medical |
3 |
P, O |
04-Feb-99 |
Busulfex
is used in combination with
cyclophosphamide as
a conditioning regimen prior to allogeneic hematopoietic
progenitor cell transplantation for chronic myelogenous leukemia |
|
N020955 |
Ferrlicit |
Sodium
Ferric Gluconate Complex |
R&D Lab |
1 |
P |
18-Feb-99 |
Ferrlicit is
indicated for the treatment of iron deficiency anemia in
patients undergoing chronic hemodialysis who are receiving
supplemental erythropoietin therapy. |
|
N021041 |
DepoCyt |
Cytarabine
Liposome |
Depotech |
3 |
P, O |
01-Apr-99 |
DepoCyt
is indicated for the
intrathecal treatment of lymphomatous meningitis. |
|
N021007 |
Agenerase |
Amprenavir |
Glaxo Wellcome |
1 |
P |
15-Apr-99 |
Agenerase is a
protease inhibitor that is indicated, in combination with other
antiretroviral agents, for the treatment of HIV-1 infection. |
|
N021039 |
Agenerase |
Amprenavir |
Glaxo Wellcome |
3 |
P |
15-Apr-99 |
Agenerase is a
protease inhibitor that is indicated, in combination with other
antiretroviral agents, for the treatment of HIV-1 infection. |
|
N020766 |
Xenical |
Orlistat |
Hoffmann-La Roche |
1 |
P |
23-Apr-99 |
Xenical is indicated
for obesity management including weight loss and weight
maintenance when used in conjunction with a reduced-calorie
diet. Xenical is also indicated to reduce the risk for weight
re-gain after prior loss. |
|
N021042 |
Vioxx |
Rofecoxib |
Merck |
1 |
P |
20-May-99 |
Vioxx is indicated
for the relief of the signs and symptoms of osteoarthritis, for
the management of acute pain and for the treatment of primary
dysmenorrhea. |
|
N021052 |
Vioxx |
Rofecoxib |
Merck |
3 |
P |
20-May-99 |
Vioxx is indicated
for the relief of the signs and symptoms of osteoarthritis, for
the management of acute pain and for the treatment of primary
dysmenorrhea. |
|
N021071 |
Avandia |
Rosiglitazone Maleate |
SmithKline Beecham |
1 |
P |
25-May-99 |
Avandia is indicated
for the treatment of type 2 diabetes mellitus as monotherapy or
in combination with metformin. |
|
N021066 |
Zaditor |
Ketotifen
Fumarate |
Ciba Vision |
1 |
P |
02-Jul-99 |
Zaditor is indicated
for the prevention of itching of the eye due to allergic
conjunctivitis. |
|
N021073 |
Actos |
Pioglitazone Hydrochloride |
Takeda America |
1 |
P |
15-Jul-99 |
Actos is indicated
for the improvement of glycemic control in patients with type 2
diabetes as monotherapy, or in combination with a sulfonylurea,
metformin or insulin when diet and the single agent does not
result in adequate glycemic control. |
|
N021036 |
Relenza |
Zanamivir |
Glaxo Wellcome |
1 |
P |
26-Jul-99
|
Relenza is indicated
for the treatment of uncomplicated acute illness due to
influenza virus in adults and adolescents twelve years and older
who have been symptomatic for no more than two days. |
|
N021045 |
Plan B |
Levonorgestrel |
Womens Capitol |
3 |
P |
28-Jul-99
|
Plan B is indicated
as an emergency contraception. |
|
N021057 |
Antagon |
Ganirelix
Acetate |
Organon, Inc. |
1 |
P |
29-Jul-99 |
Antagon is indicated
for the inhibition of premature LH surges in women undergoing
controlled ovarian hyperstimulation. |
|
N021012 |
Neotect |
Technetium
Tc-99m Depreotide Kit |
Diatide |
1 |
P |
03-Aug-99 |
Technetium Tc-99m
Depreotide is indicated for patients presenting with pulmonary
lesions on computed tomography and/or chest x-ray who have known
malignancy or who are highly suspect for malignancy. |
|
N021029 |
Temodar |
Temozolomide |
Schering |
1 |
P, O |
11-Aug-99 |
Temodar is indicated
for the treatment of adult patients with refractory anaplastic
astrocytoma, i.e., patients at first relapse who have
experienced disease progression on a drug regimen containing a
nitrosourea and procarbazine. |
|
N021083 |
Rapamune |
Sirolimus |
Wyeth-Ayerst |
1 |
P |
15-Sep-99
|
Rapamune is indicated
for prophylaxis of organ rejection in patients receiving renal
transplants. |
|
N050778 |
Ellence |
Epirubicin
Hydrochloride |
Pharmacia & Upjohn |
1 |
P, O |
15-Sep-99 |
Ellence is indicated
as a component of adjuvant therapy in patients with evidence of
axillary node tumor involvement following resection of primary
breast cancer. |
|
N050747 |
Synercid
I.V |
Quinupristin; Dalfopristin |
Rhone Poulenc Rorer |
1 |
P |
21-Sep-99 |
Synercid is
indicated for the treatment of patients with serious or
life-threatening infections associated with vancomycin-resistant
Enterococcus faecium (VREF) bacteremia. |
|
N020793 |
Cafcit |
Caffeine
Citrate |
Oread Pediatric
Roxane Dev. |
2 |
P, O |
21-Sep-99 |
Cafcit is indicated
for the short term treatment of apnea of prematurity in infants
between 28 and 33 weeks gestational age. |
|
N021079 |
Alamast |
Pemirolast
Potassium |
Santen |
1 |
P |
24-Sep-99 |
Alamast is indicated
for the prevention of itching of the eye due to allergic
conjunctivitis. |
|
N021087 |
Tamiflu |
Oseltamivir Phosphate |
Hoffmann-La Roche |
1 |
P |
27-Oct-99 |
Tamiflu is indicated
as a treatment of influenza A and B. |
|
N020884 |
Aggrenox |
Aspirin;
Dipyridamole |
Boehringer Ingelheim |
4 |
P |
22-Nov-99 |
Aggrenox is indicated
to reduce the risk of stroke in patients who have had transient
ischemia of the brain or completed ischemic stroke due to
thrombosis. |
|
N021009 |
Alocril |
Nedocromil
Sodium |
Allergan |
3 |
P |
08-Dec-99 |
Alocril is indicated
for the treatment of itching associated with allergic
conjunctivitis. |
|
N021075 |
Nutropin
Depot
|
Somatropin
rDNA Origin
|
Genentech |
3 |
P, O |
22-Dec-99 |
Nutropin Depot is
indicated for the long-term treatment of growth failure due to a
lack of adequate endogenous GH secretion for once or
twice-a-month administration. |
|
N020845 |
INOmax |
Nitric
Oxide |
INO Therapeutics |
1 |
P, O |
23-Dec-99 |
INOmax in conjunction
with ventilatory support and other appropriate agents, is
indicated for the treatment of term and near-term (>34 weeks)
neonates with hypoxic respiratory failure associated with
clinical or echocardiographic evidence of pulmonary
hypertension, where it improves oxygenation and reduces the need
for extracorporeal membrane oxygenation. |
|
N021055 |
Targretin |
Bexarotene |
Ligand Pharm |
1 |
P, O |
29-Dec-99 |
Targretin is
indicated for the treatment of cutaneous manifestations of
cutaneous T-cell lymphoma in patients who are refractory to at
least one prior systemic therapy. |
