Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal…
Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J
December 16, 2013 by Leave a Comment
Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension
March 25, 2013 by Leave a Comment
For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA. “We remain confident that…
Merck’s Combination Of Ezetimibe And Atorvastatin Back On NDA Path
January 3, 2013 by 1 Comment
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed…
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