je.st
news
Tag: fda approval
Titan Spine Receives FDA Approval For Next Generation nanoLOCKTM Surface Technology
2014-11-14 08:05:49| surfacefinishing News Articles
Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoskeleton line of interbody fusion implants featuring its next-generation nanoLOCKTM surface technology
Tags: technology
generation
surface
approval
UPDATE 1-Dr Reddy's gets FDA approval for Roche drug generic; shares at record high
2014-11-07 15:21:55| Biotech - Topix.net
Indian drugmaker Dr Reddy's Laboratories Ltd said on Friday it has received final approval from the U.S. Food and Drug Administration to make a cheaper version of Roche Holding AG's antiviral Valcyte, sending its stock to a record high. The move comes after Ranbaxy Laboratories Ltd said on Thursday that FDA had stripped the company of its tentative approval to launch the first copy of the drug due to quality control issues at its manufacturing plants.
Lannett Receives FDA Approval for Letrozole Tablets USP 2.5 mg
2014-10-30 13:22:43| Biotech - Topix.net
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Letrozole Tablets USP, 2.5 mg, the therapeutic equivalent to the reference listed drug, FemaraA Tablets, 2.5 mg, of Novartis Pharmaceuticals Corporation. According to IMS, for the year ended September 2014 total sales of Letrozole Tablets USP, 2.5 mg, at Average Wholesale Price were approximately $359 million.
Tags: approval
mg
receives
tablets
Merck & Co. Wins U.S. FDA Approval of New Type of Sleeping Pill
2014-08-14 09:59:54| Biotech - Topix.net
Merck & Co., the second-largest U.S. drugmaker, won approval to sell its treatment for insomnia, a new type of drug considered to have fewer side effects than older pills such as Ambien.
India's Ranbaxy gets FDA approval for Novartis's Diovan generic
2014-06-27 10:50:23| Chemicals - Topix.net
India's Ranbaxy Laboratories Ltd has received approval from the U.S. Food and Drug Administration to launch a cheaper copy of Novartis AG's blood pressure pill Diovan, bolstering its outlook after a raft of regulatory bans for poor production quality at its India facilities dented investor sentiment.
Tags: approval
generic
fda
indias
Sites : [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] next »