FDA: Samsca May Cause Liver Damage
Use should be time-restricted or avoided in some patients
Industry News
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).
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