Home fda
 

Keywords :   


Tag: fda

Mercks BRIDION (sugammadex) Receives FDA Approval for the Reversal of Neuromuscular Blockade Induced by Rocuronium and Vecuronium in Adults Undergoing Surgery

2015-12-17 23:52:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved BRIDION (sugammadex) Injection 100 mg/mL (equivalent to 108.8 mg/mL sugammadex sodium) for the reversal of neuromuscular blockade (NMB) induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. Language: English Contact: MerckMedia Contacts:Pamela Eisele, 267-305-3558Doris Li, 908-740-1903orInvestor Contacts:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 read more

Tags: approval adults surgery induced

 

FDA approves cheaper version of Sanofi's bestselling insulin; it's from Eli Lilly, Boehringer

2015-12-17 01:17:36| Biotech - Topix.net

Federal health officials have approved a cheaper version of the world's top-selling insulin from Sanofi for millions of U.S. patients with diabetes. The Food and Drug Administration approved a new form of Sanofi's pen-like injector, Lantus, from drugmakers Eli Lilly and Co.

Tags: version cheaper eli bestselling

 
 

FDA Issues Warning Letters\n

2015-12-16 06:00:00| Happi Breaking News

Dr. Brandt and Episcience hear from the Agency.

Tags: issues warning fda issues warning

 

FDA Approves Expanded Age Indication for GARDASIL 9 in Males

2015-12-15 23:07:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. GARDASIL 9 Now Approved for Males 16 through 26 Years of Age for the Prevention of Anal Cancers and Genital Warts Caused by Nine HPV types KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orDeb Wambold, 215-652-2913orInvestors:Teri Loxam, 908-740-1986orJustin Holko, 908-740-1879 Media Capsule: Please Activate Javascript !function(d, s, id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https',dt=new Date().getTime();if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+"://s3.amazonaws.com/contentcapsule.com/clients/Merck/tags/4ef0f659-dc5f-471f-a926-02d1aa18adfe_reg_frame.js?dt="+dt;fjs.parentNode.insertBefore(js,fjs);}}(document,"script","contentcapsule-embed-4ef0f659-dc5f-471f-a926-02d1aa18adfe"); read more

Tags: in age expanded indication

 

FDA panel rejects Merck claim Zetia/Vytorin cut heart risk

2015-12-15 10:29:34| Biotech - Topix.net

Dec 14 Merck & Co should not be allowed to claim that its cholesterol-lowering drugs Zetia and Vytorin reduce the risk of heart attacks and strokes in patients with coronary heart disease, an advisory committee to the U.S. Food and Drug Administration concluded on Monday.

Tags: heart risk cut panel

 

Sites : [61] [62] [63] [64] [65] [66] [67] [68] [69] [70] [71] [72] [73] [74] [75] [76] [77] [78] [79] [80] next »