Industry News

Intranasal Ketorolac Cleared for Pain Management

June 14, 2010

A novel prescription intranasal formulation of ketorolac tromehtamine (Sprix Nasal Spray), a non-steroidal anti-inflammatory drug, has been approved for the short-term management of acute moderate to moderately severe pain that requires analgesia at the opioid level.
 

GnRH Agonist Safety Is Under Review

June 14, 2010

The FDA is conducting a safety review of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs used primarily as a treatment for prostate cancer.
 

Home Hemodialysis Safety Device Approved

June 14, 2010

The Redsense safety device, which is designed to detect venous needle displacement during hemodialysis (HD), has received FDA approval for home/self use during home HD, according to the device's manufacturer, Redsense Medical.
 

Company Introduces Its Novel Male Sling for SUI

June 14, 2010

San Francisco-based Coloplast has announced the debut of a new sling for treating male stress urinary incontinence (SUI).
 

Lower Dosage Strength Sirolimus Tablets Available

June 14, 2010

A lower dosage strength sirolimus (Rapamune) tablet is now commercially available, according to the drug's maker, Pfizer Inc., of New York.
 

New Device May Facilitate Kidney Cancer Diagnosis

June 14, 2010

Cook Medical, of Bloomington, Ind., has introduced BIGopsy Backloading Biopsy Forceps, a device that has a 4 mm3 biopsy cup to obtain large renal or ureteral tissue specimens for cancer diagnosis.
 

Colchicine Formulation Cleared for Preventing Gout Flares

November 19, 2009

Colcrys, a new colchicine formulation, has received marketing clearance for the prevention of gout flares.
 

Valrubicin Is Reintroduced for the Treatment of CIS

October 16, 2009

Endo Pharmaceuticals, of Chadds Ford, Pa., has reintroduced Valstar (valrubicin) for the treatment of carcinoma in situ (CIS) of the urinary bladder that is refractory to treatment with Bacillus-Calmette-Guérin (BCG).
 

Patent is Filed for Device To Ease Catheter Insertion

October 16, 2009

Urovalve, of Newark, N.J., has filed a patent for a device that facilitates insertion of catheters, such as Foley catheters, the company said.
 

Anti-CMV Drug Cleared for Pediatric Transplant Patients

October 16, 2009

The FDA has approved Valcyte (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant recipients (aged four months to 16 years) who are at high risk of developing the disease.
 

Orally Dissolving Tablets for Diabetic Gastroparesis Cleared

October 16, 2009

Salix Pharmaceuticals has receiving marketing clearance for Metozolv (metoclopramide HCl) ODT (orally dissolving tablets) 5 mg and 10 mg orally disintegrating tablets for the relief of diabetic gastroparesis and symptomatic documented gastroesophageal reflux (GERD).
 

FDA Approves Aliskiren/Valsartan Combination Pill

October 16, 2009

FDA has approved Valturna (aliskiren and valsartan) tablets, which the drug's maker, Novartis, of East Hanover, N.J., said is the first and only product to target two key points in the renin angiotensin aldosterone system (RAAS).
 

Tacrolimus Cleared for Use with MMF in Renal Transplant Patients

July 23, 2009

Astellas Pharma US, in Deerfield, Ill., has received approval for the use of Prograf (tacrolimus) in conjunction with mycophenolate mofetil (MMF) in kidney transplant recipients.
 

First and Only Topical Gel for Overactive Bladder Cleared

July 23, 2009

Watson Pharmaceuticals, Corona, Calif., has received approval for Gelnique (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder (OAB).
 

Hyponatremia Drug Receives Marketing Clearance

July 23, 2009

The FDA has approved Samsca tablets (tolvaptan) to treat hyponatremia, one of the most common electrolyte disorders seen in hospitalized patients.
 

Panel Recommends Approval of Drug for Refractory Gout

July 23, 2009

The FDA's Arthritis Drugs Advisory Committee has recommended that Krystexxa (pegloticase) be approved for treating refractory chronic gout.
 

Cook Medical to Market Pneumatic Lithotripter

July 23, 2009

As a result of a partnership with LMA Urology, of Gland, Switzerland, Cook Medical, of Bloomington, Ind., has added a new lithotripter to its kidney stone treatment line.
 

BPH Medication to Be Tested in an Extended Phase 3 Study

July 23, 2009

Æterna Zentaris Inc., of Quebec City, Canada, has announced the opening of an extended phase 3 study of cetrorelix, a treatment for benign prostatic hyperplasia (BPH).
 

Probiotic for Dietary Supplement for Kidney Health Introduced

May 05, 2009

Kibow Biotech, Inc., of Newtown Square, Pa., has launched Kibow Biotics, a scientifically formulated and clinically tested dietary supplement that helps maintain healthy kidney function.
 

Premixed Hyponatremia Drug Now Commercially Available

May 05, 2009

Astellas Pharma US, Inc., of Deerfield, Ill., has announced the commercial availability of conivaptan hydrochloride injection (Vaprisol) premixed in 5% dextrose.
 

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