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. FDA also approved a new pediatric oral solution formulation for the drug that will enable easier administration to these patients.

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.

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).

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

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