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NME Drug and New Biologic Approvals in 1999

Updated through December 31, 1999

NDA Number Proprietary Name Established Name Applicant Review Classification Approval Date Indication


Pletal Cilostazol Otsuka Pharm S 15-Jan-99

Pletal is indicated for the treatment of intermittent claudication.


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.


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.


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.


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.


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.


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.


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.


Zaditor Ketotifen Fumarate Ciba Vision P 02-Jul-99 Zaditor is indicated for the prevention of itching of the eye due to allergic conjunctivitis.


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.


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.


Antagon Ganirelix Acetate Organon P 29-Jul-99 Antagon is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.


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.


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.


Sonata Zaleplon Wyeth-Ayerst S 13-Aug-99 Sonata is indicated for the short-term treatment of insomnia.


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.


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.


Rapamune Sirolimus Wyeth-Ayerst P 15-Sep-99 Rapamune is indicated for prophylaxis of organ rejection in patients receiving renal transplants.


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.


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.


Alamast Pemirolast Potassium Santen P 24-Sep-99 Alamast is indicated for the prevention of itching of the eye due to allergic conjunctivitis.


Tikosyn Dofetilide Pfizer S 01-Oct-99 Tikosyn is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.


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).


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.


Tamiflu Oseltamivir Phosphate Hoffmann-La Roche P 27-Oct-99 Tamiflu is indicated as a treatment of influenza A and B.


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.


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.


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.


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.


Solage Mequinol; Tretinoin Bristol-Myers
S 10-Dec-99 Solage is indicated for the treatment of solar lentigines.


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.


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.


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.


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.


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).


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