Clinical

Articles

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%

Pipeline Preview

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)

FDA Actions in Brief December 2012

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

Stendra (Avanafil): A new oral phosphodiesterase-5 inhibitor indicated 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

FDA Pipeline Preview, March 2012 (ViroPharma, Novartis, Amgen, Del Mar Pharmaceuticals, CSL Behring, Genentech, Salix, Gilead, Pfizer, Repligen)

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.

New label information to advise that GnRH agonists for prostate cancer could increase risk of diabetes and cardiovascular diseases

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.

Gout: Overview and newer therapeutic developments

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

Erectile dysfunction and premature ejaculation: underlying causes and available treatments

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

Urology