CDER NME Approvals in Calendar Year 1999

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FDA/Center for Drug Evaluation and Research

CDER NME Approvals in Calendar Year 1999
Updated through December 31, 1999

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.

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

Date created: March 5, 2004; updated January 19, 2006