Approved Drugs for Nephrology/Urology

Drugs Approved in 2008

Drugs Approved in 2007

• Doribax (doripenem); For the treatment of intra-abdominal infections and urinary tract infections; Johnson & Johnson; Approved October 2007
• Mircera (methoxy polyethylene glycol-epoetin beta); For the treatment of anemia associated with chronic renal failure; Hoffman La-Roche; Approved November 2007
• Torisel (temsirolimus); For the treatment of renal cell carcinoma; Wyeth Pharms; Approved May 2007

Drugs Approved in 2006

Drugs Approved in 2005

• Vaprisol (conivaptan); For the treatment of euvolemic hyponatremia; Astellas; Approved December 2005

Drugs Approved in 2004

• Fosrenol, lanthanum carbonate; For the treatment of hyperphosphatemia related to kidney dysfunction; Shire Pharmaceuticlas; Approved October, 2004
• Sanctura (trospium chloride); For the treatment of overactive bladder with symptoms of urge urinary incontinence; Indevus Pharmaceuticals; Approved May, 2004
• Sensipar (cinacalcet); For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients; Amgen; Approved March 2004
• Vesicare (solifenacin succinate); For the treatment of overactive bladder with symptoms of urge urinary incontinence; Yamanouchi, GlaxoSmithKline; Approved November, 2004

Drugs Approved in 2003

• Fabrazyme (agalsidase beta); For the treatment of Fabry disease in adult patients; Genzyme; Approved April 2003
• Oxytrol (oxybutynin transdermal system); For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.; Watson Pharmaceuticals; Approved March 2003
• UroXatral (alfuzosin HCl extended-release tablets); For the treatment of of the signs and symptoms of benign prostatic hyperplasia; Sanofi-Synthelabo; Approved June 2003

Drugs Approved in 2002

• Eligard (leuprolide acetate); For the palliative treatment of advanced prostate cancer; Atrix Laboratories; Approved January 2002
• Mesnex; Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide); Bristol-Myers Squibb, Baxter Healthcare; Approved March 2002

Drugs Approved in 2001

• dutasteride; For the treatment of symptomatic benign prostatic hyperplasia; GlaxoSmithKline; Approved November 2001
• Invanz; Once-daily injectable treatment for bacterial infections; Merck; Approved November 2001
• PhosLo; Oral capsules and gelcaps for the control of hyperphosphatemia in end stage renal failure; Braintree Laboratories; Approved April 2001
• Trelstar LA; Intramuscular injection for the treatment of advanced stage prostate cancer; Debiopharm; Approved June 2001

Drugs Approved in 2000

• Cefazolin and Dextrose USP; Respiratory tract infections; B Braun Medical; Approved July 2000
• Detrol LA (tolterodine tartrate); For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency; Pharmacia & Upjohn; Approved December 2000
• Hectorol (Doxercalciferol) Injection; To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis; Bone Care International; Approved April 2000
• Rapamune (sirolimus) Tablets; For treatment of kidney rejection; Wyeth-Ayerst Laboratories; Approved August 2000
• Renagel (sevelamer hydrochloride) Tablet; For the reduction of serum phosphorus in patients with end-stage renal disease (ESRD); GELTEX PHARMACEUTICALS; Approved July 2000
• Trelstar Depot (Injectable Triptorelin Pamoate); For the palliative treatment of advanced prostate cancer; Debio Rechereche Pharmaceutique, Target Research Associates; Approved June 2000
• Venofer (iron sucrose injection); For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis; Luitpold Pharmaceuticals; Approved November 2000
• Viadur (leuprolide acetate implant); For pain relief in men with advanced prostate cancer; Alza; Approved March 2000

Drugs Approved in 1999

• Ditropan XL (oxybutynin chloride); Treatment for overactive bladder; Alza; Approved June 1999
• Levaquin; Treatment for urinary tract infection; R.W. Johnson; Approved July 1999
• Tequin; Tequin (Injectable and Tablet); Bristol-Myers Squibb; December, 1999

Drugs Approved in 1998

• Detrol tablets; Treatment for an overactive bladder; Pharmacia & Upjohn; Approved March 1998
• Ditropan XL Tablets; Treatment for and Overactive Bladder; Alza; Approved December 1998
• Proscar; Treatment for complication relating to benign prostatic hyperplasia (BPH); Merck; Approved April 1998
• RenaGel; Treatment for Renal Disease; Geltex; Approved November 1998
• Simulect; Treatment for acute organ transplant rejection; Novartis; Approved May 1998
• Zemplar; Treatment of secondary hyperparathyroidism associated with chronic renal failure; Abbott Laboratories; Approved April 1998

Drugs Approved in 1997

• EDEX; Treatment for erectile dysfunction; Schwarz Pharma; Approved June 1997
• FLOMAX; Treatment for benign prostatic hypertrophy (BPH); Boehringer Ingelheim; Approved October 1997
• Interstim Continence Control Therapy; Treatment for incontinence; Medtronic; Approved September 1997
• Prograf; Treatment for the prevention of kidney transplant rejection; Fujisawa Healthcare; Approved April 1997
• Zenapax; Treatment to prevent rejection of kidney transplants; Roche; Approved December 1997

Drugs Approved in 1996

• Cipro (ciprofloxacin HCl); Treatment for cystitis; Bayer; Approved April 1996
• Elmiron (pentosan polysulfate sodium); Treatment for interstitial cystitis; IVAX; Approved October 1996
• Eulexin (flutamide); Treatment for prostate cancer; Schering-Plough; Approved June 1996
• Gemzar (Gemcitabine HCl); Treatment for pancreatic cancer; Eli Lilly; Approved May 1996
• Lupron Depot (leuprolide acetate for depot suspension); Treatment for advanced prostate cancer; Abbott Laboratories; Approved January 1996
• Monurol; Treatment for uncomplicated urinary tract infection; Forest Laboratories; Approved December 1996
• Nascobal Gel (Cyanocobalamin, USP); Treatment for vitamin B-12 deficiency; Questcor Pharmaceuticals; Approved November 1996
• Seprafilm; Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery; Genzyme; Approved August 1996
• Visipaque (iodixanol); Diagnostic contrast agent; Nycomed; Approved April 1996
• Zoladex (10.8 mg goserelin acetate implant); Treatment for advanced prostate cancer; Zeneca Pharmaceuticals; Approved January 1996

Drugs Approved in 1995

• Caverject (alprostadil); Treatment for impotence; Upjohn; Approved on July 6, 1995