Uro-Oncology

Approved in March, Tlando is an oral testosterone that doesn’t require dose titration.

Livmarli is the first drug approved for Alagille syndrome.

Recent FDA action (through December 2012) related to, Rabeprazole sodium delayed-release sprinkle capsules, CXA-201, CB-215, Buprenorphine subdermal implant, LX1033, ISIS-TTR Rx, Digoxin Immune Fab, Glucagon, AAV1-FS344, Trans sodium crocetinate, Betamethasone valerate foam 0.12%

Recent FDA Approvals (through December 2012) related to (Bedaquiline, Janssen, Oseltamivir, Genetech, Apixaban, Bristol-Myers Squibb, Lomitapide, Aegerion, Varicella zoster immune globulin preparation, Cangene, Teduglutide, NPS Pharmaceuticals, Pasireotide diaspartate, Novartis, Ponatinib, ARIAD Pharmaceuticals, Influenza virus vaccine, GlaxoSmithKline, Raxibacumab, Crofelemer, Salix, Cabozantinib, Exelixis)

New molecular entity: FDA approved the soral phosphodiesterase-5 (PDE-5) inhibitor, avanafil (Stendra, Vivus) for the treatment of ED.

Recent FDA action (through June 2012) related to, Darunavir, Prezista, Janssen Therapeutics, Ridaforolimus, Merck, Tafamidis meglumine, Pfizer, mechlorethamine, Ceptaris Therapeutics, AVP-923, Avanir Pharmaceuticals, NKTR-181, Nektar Therapeutics, EDI200, Edimer Pharmaceuticals, Galeterone, TOK-001, Tokai Pharmaceuticals, Butoconazole nitrate 2% vaginal cream, Gynazole-1, Perrigo

Recent FDA action (through May 2012) related to, Loxapine, Adasuve, Alexza Pharmaceuticals, Denosumab, Xgeva, Amgen, Furiex, Takeda, Nesina, alogliptin, fixed-dose combination alogliptin and pioglitazone, Liovel, Emtricitabine and tenofovir disoproxil fumarate, Truvada, Gilead Sciences, Lorcaserin, Arena Pharmaceuticals, Eisai, Tofacitinib, Pfizer, Tafamidis, ACH-3102, Achillion, CK-2017357, Cytokinetics, Taliglucerase alfa, Elelyso, Pfizer, Carisbamate, SK Biopharmaceuticals, Vancomycin hydrochloride, Vancocin, Akorn, Watson

Recent FDA action (through April 2012) related to, Dihydroergotamine, Levadex inhalation aerosol, droxidopa, Northera, Amitriptyline 4% ketamine 2% cream, AmiKet, Afilbercept, ZALTRAP, Nav rAAV8 vector, Carbamazepine, Carbatrol, Vancomycin hydrochloride, Vancocin, Irbesartan, irbesartan-hydrochloriderothiazide, Avapro, Avalide, Fluvastatin, Lescol

Recent FDA action (through February 2012) related to C1 esterase inhibitor [human], progesterone vaginal gel 8%, meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine, denosumab, VAL-083, recombinant fusion protein linking coagulation factor VIIa with albumin, pertuzumab in combination with trastuzumab, crofelemer 125-mg tablets, emtricitabine/tenofovir disoproxil fumarate, tafamidis meglumine, synthetic version of the natural human hormone secretin, doxycycline hyclate

Recent FDA Approvals (through December 2011) related to (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).

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.

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.

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.

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

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.

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

The main objectives of gout therapy are to treat the acute attack, provide prophylaxis to prevent flares, and prevent complications associated with the deposition of urate crystals in tissues. Obesity, alcohol intake, and certain foods and medications can contribute to hyperuricemia and should be identified. Pharmacologic management remains the mainstay of treatment for chronic gout and acute attacks.

This review examines the underlying causes associated with ED and PE and evaluates currently available treatment options and those under investigation.

New molecular entity: Degarelix, a GnRH receptor antagonist, was approved on December 24, 2008, for the treatment of advanced prostate cancer

New molecular entity: Fesoterodine (Toviaz), a muscarinic receptor antagonist, was approved on October 31, 2008, for the treatment of overactive bladder

New molecular entity: Silodosin (Rapaflo), an alpha-blocker, was approved on October 8, 2008, for the treatment of the signs and symptoms of BPH

A study published in the Journal of the American Medical Association reported that use of finasteride, a 5-alpha reductase inhibitor commonly used to treat benign prostatic hyperplasia (BPH), does not appear to be associated with an increased incidence of hip fractures in men; in fact, the agent appears to decrease the risk of hip fracture.

Primary androgen deprivation therapy (PADT), the second most common treatment for localized prostate cancer following prostatectomy, is no more effective than conservative medical management for prolonging survival in most older patients with prostate cancer.

Doripenem is a carbapenem antibiotic recently approved for the treatment of complicated intra-abdominal infections (IAIs) and complicated urinary tract infections (UTIs), including pyelonephritis. An NDA has also been submitted for the use of doripenem in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Doripenem is the fourth carbapenem approved for use in the United States and exhibits many pharmacologic similarities with imipenem/cilastatin and meropenem. Doripenem has a broad spectrum of activity against various gram-positive and gram-negative aerobic and anaerobic bacteria, including many multidrug-resistant gram-negative pathogens. Improved potency against nonfermentative gram-negative bacteria has also been demonstrated with doripenem compared with other carbapenems. In clinical trials, doripenem was generally well tolerated; headache, nausea, diarrhea, and phlebitis were the most commonly reported drug-related adverse events. Because doripenem exhibits..

Temsirolimus is now approved by FDA as an antineoplastic agent for the treatment of advanced renal cell carcinoma.

Statins may reduce risk of hospitalization for sepsis in patients with chronic kidney disease (CKD) who are receiving dialysis, according to a large cohort study.

Combination therapy with an antimuscarinic agent (tolterodine extended release [ER]) and alpha1-receptor antagonist (tamsulosin) provided symptomatic benefit in men with moderate-to-severe lower urinary tract symptoms and overactive bladder, according to a large-scale, randomized, double-blind, placebo-controlled study published in the Journal of the American Medical Association (JAMA).