Toviaz (fesoterodine fumarate), manufactured by Schwarz Pharma of Zwickau, Germany, and distributed by Pfizer, has been approved to help patients suffering from overactive bladder (OAB).

The FDA has issued an alert to health-care professionals and the public after receiving reports of complications from the use of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Sanofi-aventis has received approval for Apidra (insulin glulisine [rDNA origin] injection) to improve glycemic control in children aged four years and older with diabetes mellitus.

Vaprisol (conivaptan hydrochloride injection) Premixed in 5% Dextrose, a new formulation of Vaprisol developed by Astellas Pharma US, Inc., has been approved for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients.

An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), the neurodegenerative disorder commonly called "Lou Gehrig's disease."

Oxford BioMedica, a leading gene therapy company in the United Kingdom, has announced an agreement with the FDA concerning a series of amendments to its phase 3 study of TroVax, a novel therapeutic vaccine for renal cancer.

Interrad Medical, Inc., of Plymouth, Minn., has received clearance of its SecurAcath peripherally inserted central catheter (PICC) with Subcutaneous Securement System, which deploys a small anchor in the subcutaneous tissue just beneath the skin to hold an indwelling catheter securely in place.

Rapaflo (silodosin), an alpha blocker marketed by Watson Pharmaceuticals, Inc., in Corona, Calif., for oral, once-daily treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) has received approval.

IRIS International, Inc., of Chatsworth, Calif., after extensive consultation with the FDA, plans to resubmit its 510(k) application for the company's NADiA PSA ultrasensitive diagnostic test with a prognostic claim for identifying post-prostatectomy patients at low risk of prostate cancer recurrence.

At the FDA's request, U.S. marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc., of Miami.