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© 2023 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2023 MJH Life Sciences™ and Formulary Watch. All rights reserved.
January 01, 2012
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).
July 01, 2011
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.
June 03, 2011
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.
June 01, 2011
Generic drugs approved by FDA (through May 2011): bromfenac ophthalmic solution 0.09%, sodium ferric gluconate complex in sucrose injection, nitrofurantoin oral suspension
May 18, 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.
May 06, 2011
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.
April 29, 2011
November 12, 2010
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.