Use should be time-restricted or avoided in some patients
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.
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.
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.
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.
San Francisco-based Coloplast has announced the debut of a new sling for treating male stress urinary incontinence (SUI).
A lower dosage strength sirolimus (Rapamune) tablet is now commercially available, according to the drug's maker, Pfizer Inc., of New York.
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.
Colcrys, a new colchicine formulation, has received marketing clearance for the prevention of gout flares.
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).
Urovalve, of Newark, N.J., has filed a patent for a device that facilitates insertion of catheters, such as Foley catheters, the company said.
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.
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 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).
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.