FDA committee to discuss three products in January

FDA's Cardiovascular and Renal Drugs Advisory Committee will meet on Jan. 14-16 to discuss three products. On Jan. 14, the committee will discuss an NDA for Northera droxidopa from Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) to treat symptomatic neurogenic orthostatic hypotension (NOH). The PDUFA date is Feb. 14. On Monday, Chelsea was up $0.15 to $3.79.

On Jan. 15, the committee will discuss an NDA for Zontivity vorapaxar ( MK-5348) from Merck & Co. Inc. (NYSE:MRK) to reduce atherothrombotic events in patients with a history of myocardial infarction. Merck declined to disclose the PDUFA date for the protease-activated receptor 1 (PAR1) antagonist that inhibits thrombin-induced platelet activation. FDA accepted the NDA for review in late July. ...