Clinical

Articles

Recent FDA Approvals (through December 2011) related to (Antares, Isentress, REMS)

FDA Actions in Brief January 2012 (Antares, Isentress, REMS)

New indication: Tadalafil once-daily 5-mg oral tablet is FDA approved for the treatment of benign prostatic hyperplasia (BPH) in patients with or without erectile dysfunction (ED).

Tadalafil (Cialis): A phosphodiesterase type 5 inhibitor for the treatment of benign prostatic hyperplasia

The 5-alpha-reductase inhibitor dutasteride is associated with markedly lower BPH-related complication rates than the alpha-blocker tamsulosin, according to analysis of 2 large trials.

American Urological Association: 5-ARI, alpha-blocker differ in number of BPH-related complications

The selective beta3-adrenoceptor agonist mirabegron effectively improves symptoms of overactive bladder and is very safe and well tolderated, according to results of a phase 3 study.

American Urological Association: Overactive bladder agent demonstrates efficacy, tolerability in phase 3 trial

Patients with metastatic castration-resistant prostate cancer treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo, according to a phase 3 study published in the May 26 issue of the New England Journal of Medicine.

Abiraterone acetate may improve survival for patients with metastatic advanced prostate cancer

Generic drugs approved by FDA (through May 2011): bromfenac ophthalmic solution 0.09%, sodium ferric gluconate complex in sucrose injection, nitrofurantoin oral suspension

First-time generic approval June 2011

Denosumab (Xgeva, Amgen) significantly increased bone metastasis-free survival for more than 4 months in men with castrate-resistant metastatic prostate cancer that had not yet spread to bone, according to results of a landmark study of Xgeva, presented at a late-breaking plenary session at the American Urological Association?s 2011 annual meeting in Washington, DC.

Denosumab increases bone metastasis-free survival in men with castrate-resistant metastatic prostate cancer

FDA has approved abiraterone acetate (Zytiga, Centocor Ortho Biotech), 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.

FDA approves Zytiga for late-stage prostate cancer

Late-breaking news: FDA approves Zytiga for late-stage prostate cancer

FDA is asking the manufacturers of gonadotropin-releasing hormone agonists to add new safety information to the Warnings and Precautions section of the drugs? labels.

Urology