NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Review
Classification |
Approval
Date |
Indication |
N020863 |
Pletal |
Cilostazol |
Otsuka
Pharm |
S |
15-Jan-99 |
Pletal is
indicated for the treatment of intermittent claudication. |
N020886 |
Panretin |
Alitretinoin |
Ligand
Pharm |
P, O |
02-Feb-99 |
Panretin
is indicated for the treatment of cutaneous lesions in patients
with AIDS-related Kaposi’s sarcoma. |
N020955 |
Ferrlecit |
Sodium
Ferric
Gluconate Complex |
R&D Lab |
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. |
N021007 |
Agenerase |
Amprenavir |
Glaxo
Wellcome |
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 |
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 |
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 |
P |
25-May-99 |
Avandia is
indicated for the treatment of type 2 diabetes mellitus as
monotherapy or in combination with metformin. |
N020862 |
Hectorol |
Doxercalciferol |
Bone Care
International |
S |
09-Jun-99 |
Hectorol
is indicated for the reduction of elevated iPTH levels in the
management of secondary hyperparathyroidism in patients
undergoing chronic renal dialysis. |
N021066 |
Zaditor |
Ketotifen
Fumarate |
Ciba
Vision |
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 |
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 |
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. |
N021057 |
Antagon |
Ganirelix
Acetate |
Organon |
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 |
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 |
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. |
N020859 |
Sonata |
Zaleplon |
Wyeth-Ayerst |
S |
13-Aug-99 |
Sonata is
indicated for the short-term treatment of insomnia. |
N020984 |
Raplon |
Rapacuronium Bromide |
Organon |
S |
18-Aug-99 |
Raplon is
indicated for outpatients and inpatients as an adjunct to
general anesthesia to facilitate tracheal intubation, and to
provide skeletal muscle relaxation during surgical procedures. |
N020973 |
Aciphex |
Rabeprazole Sodium |
Eisai (US) |
S |
19-Aug-99 |
Aciphex is
indicated for 1) healing of erosive or ulcerative
gastroesophageal reflux disease (GERD); 2) maintenance of
healing of erosive or ulcerative GERD; 3) healing of duodenal
ulcer; 4) treatment of pathological hypersecretory conditions,
including Zollinger-Ellison Syndrome. |
N021083 |
Rapamune |
Sirolimus |
Wyeth-Ayerst |
P |
15-Sep-99 |
Rapamune
is indicated for prophylaxis of organ rejection in patients
receiving renal transplants. |
N050778 |
Ellence |
Epirubicin
Hydrochloride |
Pharmacia
& Upjohn |
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
IV |
Quinupristin; Dalfopristin |
Rhone
Poulenc Rorer |
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. |
N021079 |
Alamast |
Pemirolast
Potassium |
Santen |
P |
24-Sep-99 |
Alamast is
indicated for the prevention of itching of the eye due to
allergic conjunctivitis. |
N020931 |
Tikosyn |
Dofetilide |
Pfizer |
S |
01-Oct-99 |
Tikosyn is
indicated for the conversion of atrial fibrillation and atrial
flutter to normal sinus rhythm. |
N020796 |
Comtan |
Entacapone |
Orion |
S |
19-Oct-99 |
Comtan is
indicated as an adjunct to levodopa/carbidopa to treat patients
with idiopathic Parkinson’s Disease who experience the signs and
symptoms of end-of-dose "wearing-off" (so called "fluctuating"
patients). |
N020753 |
Aromasin |
Exemestane |
Pharmacia
& Upjohn |
S, O |
21-Oct-99 |
Aromasin
is indicated for the treatment of advanced breast cancer in
postmenopausal women whose disease has progressed following
tamoxifen therapy. |
N021087 |
Tamiflu |
Oseltamivir Phosphate |
Hoffmann-La Roche |
P |
27-Oct-99 |
Tamiflu is
indicated as a treatment of influenza A and B. |
N020744 |
Curosurf |
Poractant
Alfa |
Dey Labs |
S, O |
18-Nov-99 |
Curosurf
is indicated for the treatment (rescue) of Respiratory Distress
Syndrome (RDS) in premature infants. |
N021035 |
Keppra |
Levetiracetam |
UCB Pharm |
S |
30-Nov-99 |
Keppra is
indicated as an adjunctive therapy in the treatment of partial
onset seizures in adults with epilepsy. |
N020965 |
Levulan
Kerastick |
Aminolevulinic Acid Hydrochloride |
DUSA Pharm |
S |
03-Dec-99 |
Levulan
Kerastick plus blue light illumination using the BLU-U Blue
Light Photodynamic Therapy Illuminator is indicated for the
treatment of non-hyperkeratotic actinic keratoses of the face
and scalp. |
N020937 |
Optimark |
Gadoversetamide |
Mallinckrodt |
S |
08-Dec-99 |
Optimark
is indicated for the use with magnetic resonance imaging (MRI)
in patients with an abnormal blood barrier or abnormal
vascularity of the brain, spine and associated tissues; and with
MRI to provide contrast enhancement and facilitate visualization
of lesions with abnormal vascularity in the liver in patients
who are highly suspect for liver structural abnormalities
identified on computerized tomography. |
N020922 |
Solage |
Mequinol;
Tretinoin |
Bristol-Myers
Squibb |
S |
10-Dec-99 |
Solage is
indicated for the treatment of solar lentigines. |
N021085 |
Avelox |
Moxifloxacin Hydrochloride |
Bayer |
S |
10-Dec-99 |
Avelox is
indicated for the treatment of acute bacterial sinusitis, acute
bacterial exacerbation of chronic bronchitis, community-acquired
pneumonia. |
N021038 |
Precedex |
Dexmedetomidine Hydrochloride |
Abbott
Labs |
S |
17-Dec-99 |
Precedex
is indicated for the sedation of initially intubated and
mechanically ventilated adult patients in an ICU setting. |
N021061 |
Tequin |
Gatifloxacin |
Bristol-Myers Squibb |
S |
17-Dec-99 |
Tequin is
indicated for the treatment of acute bacterial sinusitis,
community-acquired pneumonia, acute bacterial exacerbation of
chronic bronchitis, urinary tract infections, pyelonephritis,
and uncomplicated gonorrhea. |
N020845 |
INOmax |
Nitric
Oxide |
INO
Therapeutics |
P, O |
23-Dec-99 |
INOmax is
indicated an an 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 or
pulmonary hypertension, where it improves oxygenation and
reduces the need for extracorporeal membrane oxygenation. |
N021055 |
Targretin |
Bexarotene |
Ligand
Pharm |
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. |
Date created: March 5, 2004; updated
January 19, 2006