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CDER NME Approvals in Calendar Year 2001

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 CDER NME Approvals in Calendar Year 2001
 Updated through December 31, 2001

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.

Review Classification:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - Products that do not qualify for priority review.
O -  Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

To access approval letters, labels, and review packages, go to Drugs at FDA Logo links back to Initial Search Page


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