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 The leading web portal for pharmacy resources, news, education and careers May 27, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 27, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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4/27/17 - ZYDUS CADILA GETS USFDA NOD FOR ANTI-HYPERTENSIVE TABLETS
Pharmaceutical company Zydus Cadila has received final approval from the US Food and Drug Administration to market Olmesartan Medoxomil tablets in the US market. The approval is for 5 milligram, 20 milligram and 40 milligram strengths of the anti-hypertensive Olmesartan. estimated sales for Olmesartan is $982 million for twelve months to Feb 2017.
4/26/17 - Addivant product receives FDA approval [New Times, The (Rwanda)]
Addivants nonylphenol-free stabiliser Weston 705 has received formal approval from the US Food and Drug Administration for use in infant formula and human milk plastics packaging. John Steitz, Addivants chief executive, said: FDA has tightened even further its scrutiny on infant formulation using the most stringent screening procedures for this...
4/26/17 - Bausch + Lomb Receives 510(k) Clearance From FDA For Vitesse?, The First And Only Hypersonic, Open-Port Vitrectomy System
Valeant Pharmaceuticals International, Inc.' s wholly owned subsidiary, Bausch+ Lomb, today announced it has received 510 clearance from the U.S. Food and Drug Administration for Vitesse?, the first and only hypersonic device for vitreous removal, which uses a novel, single-needle design and a continuously open-port system. "The successful cle
4/26/17 - FDA Approves MyoCycle FES Bike from MYOLYN
FES-powered stationary bikes MyoCycle Home and MyoCycle Pro have received FDA 510(k) clearance, according to an announcement from their manufacturer, Gainesville, Fla-based MYOLYN.
4/26/17 - FDA Approves XATMEP?, the First and Only Ready-To-Use Methotrexate Oral Solution
Silvergate Pharmaceuticals, Inc., leaders in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration approved XATMEP Oral Solution, the first and only FDA- approved methotrexate oral solution. "XATMEP is an exciting product in that it provides an FDA
4/26/17 - FDA Clears Flex Pharma's FLX-787 to Commence US Phase 2 Trial in ALS Under IND
Flex Pharma, Inc., focused on developing treatments for cramps and spasms associated with the severe neurological diseases of amyotrophic lateral sclerosis, multiple sclerosis and peripheral neuropathies such as Charcot-Marie-Tooth, today announced that the Company's investigational new drug application for FLX-787 for patients with ALS is...
4/26/17 - Gout Therapeutics Market Analysis By Drug Class (Nonsteroidal Anti-inflammatory Drugs [NSAIDs], Corticosteroids, Colchicine, Urate-Lowering Agents), By Disease Condition (Acute Gout, Chronic Gout), And Segment Forecasts, 2014 - 2025
The global gout therapeutics market is expected to reach a value of USD 8.3 billion By 2025, based on a new report by Grand View Research, Inc.. In December 2015, AstraZeneca's product, Zurampic, in combination with xanthine oxidase inhibitor received an approval from the U. S. FDA to treat gout. Later in February 2016, the European Commission appr
4/26/17 - Impax Announces FDA Approval and Launch of a Generic Version of Vytorin (Ezetimibe/Simvastatin Tablets)
Impax Laboratories, Inc., a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration approval for a generic version of Vytorin , 10/ 10, 10/ 20, 10/ 40 and 10/ 80 mg, and immediately initiated commercialization activities of this first-to-market opportunity. "We are pleased to be one of the firs
4/26/17 - Inspirion Delivery Sciences Receives FDA Approval for RoxyBond? (oxycodone hydrochloride) tablets CII, the First and Only Immediate Release Opioid Analgesic with Abuse-Deterrent Label Claims
Inspirion Delivery Sciences, LLC announced that the United States Food and Drug Administration has approved RoxyBond? tablets, for oral use, CII, indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. RoxyBond is an abuse-deterrent formulation of oxycodone that uses
4/26/17 - joimax Announces 510(k) Clearance for Its Endovapor 2 Multi Radio Frequency System During Its First Presentation at the Annual Scientific Meeting of the American Association of Neurological Surgeons (AANS) 2017, in Los Angeles
joimax , the German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery, today announced it has received 510 clearance from the U.S. Food and Drug Administration to market its Endovapor 2 Multi Radio Frequency System. joimax received 510 clearance from the U.S. Food and Drug Administrati
4/26/17 - LimFlow Receives FDA Approval for U.S. Feasibility Study of Minimally-Invasive Technology Designed to Restore Perfusion in No Option Critical Limb Ischemia Patients
LimFlow SA, developer of minimally-invasive technology for the treatment of end-stage critical limb ischemia, a severe form of peripheral artery disease, announced today that the U.S. Food and Drug Administration has approved its Investigational Device Exemption for a feasibility study of the LimFlow Percutaneous Deep Vein Arterialization System.
4/26/17 - Mazor Robotics Receives FDA Clearance for Spinal Deformity Correction Planning Software for the Mazor X Surgical Assurance Platform
By a News Reporter-Staff News Editor at Computer Weekly News Mazor Robotics Ltd., a pioneer and leader in the field of surgical guidance systems, has received FDA clearance for its Mazor X Align? software. Mazor X Align leverages Mazor Robotics' extensive experience in pre-operative planning, image processing, computerized anatomy recognition,
4/26/17 - Medical device developer, Lumendi appoints Joliet-based regional sales manager [Palestine News Network]
Medical device developer, Lumendi appointed a Joliet- based regional sales manager for DiLumen, a surgical device that allows gastroenterologists to see betterand conduct proceduresinside the colon, without surgery. Peter OConnell will be heading up the Midwest office as Lumendi aims for a May launch. DiLumen received FDA approval in December.
4/26/17 - Mentor MemoryGel Xtra Implant Receives FDA Approval
Mentor Worldwide LLC announces that the US Food and Drug Administration has approved its MemoryGel Xtra silicone gel-filled breast implants for marketing in the United States.
4/26/17 - Mentor Announces FDA Approval for MemoryGel XTRA Silicone Gel-Filled Breast Implants
Mentor Worldwide LLC, a global leader in breast aesthetics, today announced that it has received approval from the U.S. Food& Drug Administration to market MemoryGel Xtra silicone gel-filled breast implants in the U.S. Louis Strock,* American Board of Plastic Surgery, Diplomate. MENTOR MemoryGel Xtra implants will soon be available to cu
4/26/17 - MYOLYN Announces FDA Clearance of its MyoCycle Device
Such systems are also known as FES bikes. "FES is a very promising technology that can help many people with paralysis or muscle weakness," says MYOLYN co-founder and CEO Alan Hamlet, PhD. The MyoCycle is an affordable, easy-to-use FES bike that enables therapeutic, load-bearing exercise despite even complete paralysis.
4/26/17 - Samsung GC70 Digital Radiography System Receives FDA 510(k) Clearance
Samsung, an emerging leader in medical imaging technology, announces that the GC70 Digital Radiography system received FDA 510 clearance for the U.S. market, underscoring the company s commitment to expanding its suite of radiography products. The GC70 is leading a new generation of digital radiography systems that will make x-rays safer and
4/26/17 - SOLCO HEALTHCARE INTRODUCES OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE Tablets
Release date- 24042017- CRANBURY, NJ-Solco Healthcare today announced the launch of generic version of Daiichi-Sankyo's Benicar-HCT, Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12. 5 mg, 40/ 12.5 mg and 40 mg/25mg. Solco received its final approval by the U.S. FDA for its abbreviated New Drug Application via its parent company Prins
4/26/17 - Valeant's Subsidiary Earns FDA Clearance
Valeant Pharmaceuticals International announced its owned subsidiary Bausch+ Lomb received 510 clearance from the US Food and Drug Administration for their hypersonic vitreous removal Vitesse. The successful clearance and upcoming launch of Vitesse is another opportunity in our 2017 launch plan, which we believe will provide truly innovative...
4/25/17 - Biologics, Inc. Selected by TESARO as a Specialty Pharmacy Provider for ZEJULATM (niraparib), Approved for the Treatment of Recurrent Ovarian Cancer
Release date- 24042017- CARY, N.C.-Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by TESARO, Inc. to be a specialty pharmacy provider in the distribution network for ZEJULATM. Approved by the U.S. Food and Drug Administration on March 27, 2017, ZEJULA is a poly ADP-ribose polymerase inhibitor, for
4/25/17 - FDA Clears Alere Immunoassay Analyzer
The diagnostic system features objective results interpretation and connectivity capabilities, and can be used to evaluate lateral-flow immunoassays in a wide variety of formats.
4/25/17 - FDA Grants Diazyme 510(k) Clearance to Market Its Procalcitonin Assay for Clinical Chemistry Analyzers
Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration has granted 510 clearance to market its Procalcitonin assay. Procalcitonin, a propeptide synthesized in the C-cells of the thyroid, has been identified to be more clinically useful and superior than currently used common clinical variables and laboratory tests in
4/25/17 - Regeneron and Sanofi Announce FDA Approval of a New Once-Monthly Dosing Option for Praluent (alirocumab) Injection
TARRYTOWN, N.Y. and BRIDGEWATER, N.J., April 25, 2017/ PRNewswire/ Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration approved the companies' new supplemental Biologics License Application for a once-monthly, 300 mg dose of Praluent Injection for the treatment of adults with high low-density l
4/25/17 - Sanofi and Regeneron Announce FDA Approval of a New Once-Monthly Dosing Option for Praluent (alirocumab) Injection
BRIDGEWATER, N.J. and TARRYTOWN, N.Y., April 25, 2017/ PRNewswire/ Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved the companies' new supplemental Biologics License Application for a once-monthly, 300 mg dose of Praluent Injection for the treatment of adults with high low-density l
4/25/17 - Sanofi Receives FDA Approval of Thymoglobulin for the Prevention of Acute Kidney Transplant Rejection
'Thymoglobulin has been a well-established medication used in kidney transplantation for nearly 20 years, and this FDA approval is an important milestone for the transplant community,' said Daniel Brennan, MD, Professor of Medicine, Director of Transplant Nephrology, Barnes-Jewish Hospital of Washington University School of Medicine in St. Louis.'.
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