Drug Therapy

Mylan Inc. recently announced that its subsidiary, Mylan Pharmaceuticals Inc., has launched alfuzosin hydrochloride extended-release tablets, 10 mg, for signs and symptoms of BPH.

The FDA has approved updated drug labels for medications containing pioglitazone (Actos), an agent used to treat type 2 diabetes. The new labels are part of an update to the agency?s ongoing safety review of pioglitazone and increased risk of bladder cancer.

In premenopausal women who have repeated urinary tract infections, the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX [Bactrim, Septra DS]) appears to be more effective than cranberry capsules for preventing recurrent infections, at the risk of contributing to antibiotic resistance, Dutch researchers recently reported.

The AUA is asking the FDA to remove or alter certain language in a recent FDA alert concerning 5-alpha-reductase inhibitor therapy.

Watson Laboratories has filed an abbreviated new drug application with the FDA seeking approval to market dutasteride capsules, 0.5 mg.

Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for its RANK ligand inhibitor denosumab (XGEVA) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

The FDA has approved the first generic versions of the antibiotic levofloxacin.

The Centers for Medicare and Medicaid Services issued a final National Coverage Decision for sipuleucel-T (Provenge), requiring Medicare contractors to cover the use of the therapy for treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

The FDA has approved a new 45-mg, 6-month administration formulation of the gonadotropin releasing hormone agonist leuprolide acetate for depot suspension (Lupron Depot), for the palliative treatment of advanced prostate cancer.

The FDA is informing the public that using the diabetic medication pioglitazone (Actos) for more than 1 year may be associated with an increased risk of bladder cancer.

The investigational agent cabozantinib (XL184) shows promise for treating metastatic prostate cancer, according to a multicenter study presented at the American Society of Clinical Oncology annual meeting in Chicago.

The FDA is informing health care professionals that the "Warnings and Precautions" section of the labels for the 5-alpha-reductase inhibitor class of drugs has been revised to include new safety information about the increased risk of being diagnosed with high-grade prostate cancer, although the risk appears to be low.

Watson Pharmaceuticals, Inc. recently confirmed that its subsidiary, Watson Laboratories, Inc., filed an abbreviated new drug application (ANDA) with the FDA seeking approval to market sildenafil citrate tablets in 25-, 50-, and 100-mg doses.

The investigational agent axitinib (AG-013736) appears to significantly extend progression-free survival compared with sorafenib (Nexavar) in patients with previously treated advanced renal cell carcinoma, according to a study presented at the American Society of Clinical Oncology annual meeting in Chicago.

Patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel (Taxotere) showed a significant improvement in overall survival when treated with abiraterone acetate (ZYTIGA) plus prednisone compared with patients treated with prednisone plus placebo, the authors of a phase III trial reported.

An orally disintegrating version of the phosphodiesterase type-5 inhibitor vardenafil hydrochloride (Staxyn), a new FDA-approved treatment for erectile dysfunction, is now available in the United States.

The non-medical use of prescription drugs is thought to represent the fastest growing drug problem in the United States, and urologists aren't immune to it.

The RANK ligand inhibitor denosumab (XGEVA) appears to significantly increase bone metastasis-free survival for more than 4 months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone, results of a multicenter study indicate.

The selective beta3-adrenoceptor agonist mirabegron effectively improves symptoms of overactive bladder and is very safe and well tolerated, according to results of a North American phase III study presented yesterday.

Updated phase III clinical trial results provide further evidence that oral abiraterone acetate (ZYTIGA), which was recently approved by the FDA, is well tolerated and has significant clinical benefit in men failing previous intervention for metastatic castration-resistant prostate cancer, according to a multicenter study.

Rare atypical fractures of the femur appear to be a class effect of bisphosphonates, according to the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The FDA has approved abiraterone acetate (ZYTIGA), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel (Taxotere).

An investigational intravaginal suppository probiotic may reduce the rate of recurrent urinary tract infections in women prone to the infections, say researchers from the University of Washington, Seattle.

The advanced prostate cancer autologous cellular immunotherapy sipuleucel-T (Provenge) improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer and thus is reasonable and necessary for that indication, according to a proposed decision memo from the Centers for Medicare & Medicaid Services.

Greenstone LLC has announced that it is voluntarily conducting a recall of medicines with lot number FI0510058-A on the label, including the 5-alpha-reductase inhibitor finasteride, 5 mg tablets (90-count).