Industry News

FDA: Samsca May Cause Liver Damage

FDA: Samsca May Cause Liver Damage

Use should be time-restricted or avoided in some patients

FDA Puts Artificial Kidney on Fast Track for Approval

The FDA will be piloting three products for the treatment of end-stage renal disease (ESRD), including an artificial kidney, as part of an ongoing program to expedite the availability of medical technology.

Intranasal Ketorolac Cleared for Pain Management

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

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

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

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

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

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

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

Valrubicin Is Reintroduced for the Treatment of CIS

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

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

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

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

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

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.