Cardiovascular and Renal Drugs Advisory Committee

Cardiovascular and Renal Drugs Advisory Committee Committee Meeting September 13, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: During the morning session, the committee will discuss new drug application (NDA) 203009, lixivaptan, submitted by Cardiokine Biopharma, LLC, for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. During the afternoon session, the committee will discuss NDA 203826, phenylephrine hydrochloride injection, USP, submitted by West-Ward Pharmaceutical Corp., to increase blood pressure in acute hypotensive states, such as shock and peri-operative hypotension.

Pediatric Advisory Committee Meeting

Pediatric Advisory Committee Meeting Committee Meeting September 11, 2012 8:30 a.m. – 4:00 p.m. Agenda: On Tuesday, September 11, 2012, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Kapvay (clonidine hydrochloride), Vyvanse (lisdexamfetamine dimesylate), Ofirmev (acetaminophen), ella (ulipristal acetate), Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), LoLoestrin Fe (norethindrone acetate and ethinyl estradiol ethinyl estradiol and ferrous fumarate), Aridol (mannitol inhalation powder), Augmentin XR (amoxicillin/clavulanate potassium), Afinitor (everolimus), Moxeza (moxifloxacin hydrochloride), and Lastacaft (alcaftadine).