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Industry News
Intranasal Ketorolac Cleared for Pain Management
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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
Jody A. Charnow
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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