| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Review
Classification |
Approval
Date |
Indication |
|
N021227 |
Cancidas |
Caspofungin Acetate |
Merck Research Labs |
P |
26-Jan-01 |
Cancidas is indicated for
the treatment of invasive aspergillosis in patients who are
refractory to or intolerant of other therapies. |
|
N020825 |
Geodon |
Ziprasidone
Hydrochloride |
Pfizer |
S |
05-Feb-01 |
Geodon is indicated for the
treatment of schizophrenia. |
|
N020831 |
Foradil Aerolizer |
Formoterol
Fumarate |
Novartis Pharms |
S |
16-Feb-01 |
Foradil is indicated for
the long- term, administration in the maintenance treatment of
asthma and in the prevention of bronchospasm in adults and
children 5 years of age and older with reversible obstructive
airways disease, including patients with symptoms of nocturnal
asthma. Foradil is also indicated for the acute prevention of
exercise-induced bronchospasm (EIB) in adults and children 12
years of age and older, when administered on an occasional,
as-needed basis. |
|
N021169 |
Reminyl |
Galantamine
Hydrobromide |
Janssen Research |
S |
28-Feb-01 |
Reminyl is indicated for
the treatment of mild to moderate dementia of the Alzheimer's
type. |
|
N021257 |
Travatan |
Travoprost |
Alcon Universal |
P |
16-Mar-01 |
Travatan is indicated for
the reduction of intraocular pressure in patients with
open-angle glaucoma or ocular hypertension who are intolerant of
other intraocular pressure lowering medications or
insufficiently responsive (failed to achieve target IOP
determined after multiple measurements over time) to another
intraocular pressure lowering medication. |
|
N021275 |
Lumigan |
Bimatopros |
Allergan |
P |
16-Mar-01 |
Lumigan is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication.
|
|
N021001 |
Axert |
Almotriptan Malate |
Pharmacia & Upjohn |
S |
07-May-01 |
Axert is indicated for the
acute treatment of migraine. |
|
N021335 |
Gleevec |
Imatinib
Mesylate |
Novartis Pharms |
P, O |
10-May-01 |
Gleevec is indicated for
the treatment of patients with chronic myeloid leukemia (CML) in
blast crisis, accelerated phase, or in chronic phase after
failure of interferon-alpha therapy. |
|
N021098 |
Yasmin |
Drospirenone;
Ethinyl Estradiol |
Berlex Labs |
S |
11-May-01 |
Yasmin is indicated for
oral contraception. |
|
N021064 |
Definity |
Perflutren
Lipid Microsphere |
Dupont Pharms |
S |
31-Jul-01 |
Definity is indicated for
the treatment in patients with suboptimal echocardiograms to
opacify the left ventricular chamber and to improve the
delineation of the left ventricular endocardial border. |
|
N020920 |
Natrecor |
Nesiritide |
Scios |
S |
10-Aug-01 |
Natrecor is indicated for
the intravenous treatment of patients with acutely decompensated
congestive heart failure who have dyspnea at rest or with
minimal activity. |
|
N021223 |
Zometa |
Zoledronic Acid |
Novartis Pharms |
P |
20-Aug-01 |
Zometa is indicated for the
treatment of hypercalcemia of malignancy. |
|
N021222 |
Spectracef |
Cefditoren
Pivoxil |
TAP Pharm |
S |
29-Aug-01 |
Spectracef is indicated for
the treatment of acute bacterial exacerbation of chronic
bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and
skin structure infections. |
|
N021187 |
NuvaRing |
Etonogestrel;
Ethinyl Estradiol Vaginal Ring |
Organon |
S |
03-Oct-01 |
NuvaRing is indicated for
the prevention of pregnancy in women who elect to use this
product as a method of contraception. |
|
N021356 |
Viread |
Tenofovir
Disoproxil Fumarate |
Gilead Sciences |
P |
26-Oct-01 |
Viread is indicated to be
used in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults. |
|
N021006 |
Frova |
Frovatriptan
Succinate |
Elan Pharma |
S |
08-Nov-01 |
Frova is indicated for the
acute treatment of migraine. |
|
N021341 |
Bextra |
Valdecoxib |
Searle Pharms |
S |
16-Nov-01 |
Bextra is indicated for the
relief of signs and symptoms of osteoarthritis and adult
rheumatoid arthritis and for the treatment of primary
dysmenorrhea. |
|
N021180 |
Ortho Evra |
Norelgestromin; Ethinyl Estradiol |
RW Johnson |
S |
20-Nov-01 |
Ortho Evra is indicated for the prevention of
pregnancy. |
|
N021290 |
Tracleer |
Bosentan)
|
Actelion |
S, O |
20-Nov-01 |
Tracleer is indicated for
the treatment of pulmonary arterial hypertension. |
|
N021319 |
Avodart |
Dutasteride |
Glaxo SmithKline |
S |
20-Nov-01 |
Avodart is indicated for
the treatment of symptomatic benign prostatic hyperplasia (BPH)
in men with an enlarged prostate gland. |
|
N021337 |
Invanz |
Ertapenem
Sodium |
Merck |
S |
21-Nov-01 |
Invanz is indicated for the
following: (1) Complicated intra-abdominal infections (2)
Complicated skin and skin structure infections (3) Community
acquired pneumonia (4) complicated urinary tract infections
including pyelonephritis (5) Acute pelvic infections including
postpartum endomyometritis, septic abortion and post surgical
gynecologic infections. |
|
N021345 |
Arixtra |
Fondaparinux
Sodium |
Fonda BV |
P |
07-Dec-01 |
Arixtra is indicated for
the following: the prophylaxis of deep vein thrombosis, which
may lead to pulmonary embolism: 1) in patients undergoing hip
fracture surgery; 2) in patients undergoing hip replacement
surgery; 3) in patients undergoing knee replacement surgery. |
|
N021302 |
Elidel |
Pimecrolimus |
Novartis Pharms |
S |
13-Dec-01 |
Elidel is indicated for
short-term and intermittent long-term therapy in the treatment
of mild to moderate atopic dermatitis in non-immunocompromised
patients 2 years of age and older, in whom the use of
alternative, conventional therapies is deemed inadvisable
because of potential risks, or in the treatment of patients who
are not adequately responsive to or intolerant of alternative,
conventional therapies. |
|
N021165 |
Clarinex |
Desloratadine |
Schering |
S |
21-Dec-01 |
Clarinex is indicated for
the relief of the nasal and non-nasal symptoms of seasonal
allergic rhinitis in patients 12 years of age and older. |
