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September FDA plays

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09/05/2012 Novartis AG NVS Tobramycin inhalation powder (NDA)

FDA panel to review Tobramycin inhalation powder for mgmt of cystic fibrosis patients infected with Pseudomonas aeruginosa




09/05/2012 Salix Pharmaceuticals Ltd SLXP Crofelemer 125 mg tablets (NDA)

FDA decision on Crofelemer for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy




09/09/2012 Ironwood Pharmaceuticals, Inc. IRWD Linaclotide (NDA)

FDA decision on Linaclotide for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation




09/10/2012 Navidea Biopharmaceuticals, Inc. NEOP, NAVB Lymphoseek (NDA)

FDA decision on Lymphoseek for proposed use in intraoperative lymphatic mapping




09/13/2012 Cornerstone Therapeutics Inc. CRTX Lixivaptan (CRTX 080) (NDA)

FDA panel to review Lixivaptan for treatment of hyponatremia




09/14/2012 Gilead Sciences Inc. GILD Truvada (sNDA)

FDA decision on Truvada in new indication as HIV preventive therapy
*FDA approved Truvada as HIV preventive therapy on Jul.16


09/30/2012 NPS Pharmaceuticals Inc NPSP Gattex (NDA)

FDA decision on Gattex for proposed treatment of adult short bowel syndrome
*FDA decision date postponed to Dec.30, 2012