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 The leading web portal for pharmacy resources, news, education and careers November 20, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 20, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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11/20/14 - AZE Technology, Inc. Announces FDA Approval of Phoenix (Volume Registration Viewer)
AZE Technology today announces the U.S. Food and Drug Administration approval of Phoenix, a viewer developed with a completely new concept for efficient and accurate image interpretation. Phoenix is designed with background volume-processing performed at the same time as data input, and presents various dramatic outcomes that were not possible wi
11/20/14 - FDA approves new, hard-to-abuse hydrocodone pill
The Food and Drug Administration approved Purdue Pharma's Hysingla ER, for patients with severe, round-the-clock pain that cannot be managed with other treatments. Purdue Pharma's new drug poses a direct commercial challenge to Zogenix's much-debated drug Zohydro, a twice-a-day hydrocodone tablet approved by the FDA last year. The FDA has been unde
11/20/14 - JCI Pharmaceutical Co., Ltd. Receives Approval from US FDA for Colloidal Iodine Formulation
Tokyo, Nov 20, 2014 JCI Pharmaceutical Co., Ltd. has announced approval by the US FDA for its MN colloid iodine, a formulation utilizing a world-first technology for converting iodine into a colloidal state to make it absorbable into the body at a large doses. The new formulation converts iodine into a colloid state and further processes it to ma
11/20/14 - Purdue Pharma L.P. Receives FDA Approval for Hysingla? ER (hydrocodone bitartrate) Extended-Release Tablets CII, A Once-Daily Opioid Analgesic Formulated with Abuse-Deterrent Properties
Purdue Pharma L.P. announced that the U.S. Food and Drug Administration approved Hysingla ER extended-release tablets CII, a once-daily, single-entity medication formulated using Purdue's proprietary extended-release solid oral platform, RESISTEC?. It is the first and only hydrocodone product to be recognized by the FDA as having abuse-deterren
11/20/14 - Sheridan Healthcare Partners with Football Legend Joe Namath for Traumatic Brain Injury Research [Global Data Point]
Lee Fox, a Sheridan Healthcare Radiology Medical Director, to try hyperbaric oxygen treatment at Jupiter Medical Center. Barry Miskin, chief of surgery at Jupiter Medical Center, developed a protocol for using hyperbaric oxygen therapy for TBI and received approval from the Food and Drug Administration to launch a clinical trial. So together with J
11/20/14 - US approves new, hard-to-abuse hydrocodone pill
The FDA said the medication is difficult to crush, break or dissolve. Purdue Pharma's new drug poses a direct commercial challenge to Zogenix's much-debated drug Zohydro, a twice-a-day hydrocodone tablet approved by the FDA last year. The FDA has been under intense public pressure to combat the national epidemic of prescription opioid abuse.
11/19/14 - Mallinckrodt sues FDA over ADHD drug; reports Q4 loss [St. Louis Post-Dispatch]
But on Nov. 13, the FDA backtracked and told Mallinckrodt the drug "may not be therapeutically equivalent" and changed the classification of the drug. Mallinckrodt's generic version originally received FDA approval on Dec. 28, 2012. During a earnings call today, Mallinckrodt CEO Mark Trudeau said of the 88 million dosages prescribed only 68 confirm
11/19/14 - Ranbaxy Files Complaint Against FDA Over Revocation of Tentative Approvals For ANDAs For Esomeprazole Magnesium Delayed-Release Capsules And... [Global Data Point]
Ranbaxy Files Complaint Against FDA Over Revocation of Tentative Approvals For ANDAs For Esomeprazole Magnesium Delayed-Release Capsules And Valganciclovir Hydrochloride Tablets. FDA has said that its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time.
11/19/14 - Ranbaxy sues FDA for revoking approvals [DNA : Daily News & Analysis (India)]
Mumbai: Ranbaxy Laboratories, the company in waiting to be merged with Sun Pharma, has taken a legal recourse against the US drug regulator for revoking the tentative approvals granted for launching the generic versions of AstraZeneca's heartburn drug Nexium and Roche's antiviral Valcyte in the US. According to analysts, Ranbaxy could have gained $
11/19/14 - RANBAXY SUES USFDA FOR REVOKING DRUG APPROVALS
Ranbaxy Laboratories Ltd has sued the US Food and Drug Administration for revoking the tentative approvals of Nexium and Valcyte. The USFDA had banned export of drugs manufactured at the plants of Ranbaxy in India to the US. Ranbaxy had paid fines of $500 million in 2013 on seven counts.
11/18/14 - AdvanDx Receives FDA 510(k) Clearance for mecA XpressFISH?
AdvanDx, a leader in the development of advanced molecular diagnostic products for the diagnosis and treatment of life-threatening infections, today announced that it has received U.S. Food and Drug Administration 510 clearance for its new mecA Xpress FISH? assay for the detection of methicillin-resistant and methicillin-susceptible Staphylococ
11/18/14 - Aurora Spine Corporation : AURORA SPINE RECEIVES FDA 510(k) CLEARANCE FOR PRE-PACKAGED STERILE ZIP 51(TM) MIS INTERSPINOUS FIXATION IMPLANT
Carlsbad, California, November 18, 2014/ Marketwired/- Aurora Spine Corporation announced today that it has received U.S. "Aurora is changing spine surgery, and we are thrilled to receive FDA clearance with the ZIP 51, another key product in the Aurora Spine MIS Fusion System," said Trent J. Northcutt, President and CEO of Aurora Spine. "The new
11/18/14 - Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51(TM) MIS Interspinous Fixation Implant
Aurora Spine Corporation announced today that it has received U.S. Food and Drug Administration 510 clearance for the ZIP 51?, Aurora Spine's slimmest minimally invasive interspinous fixation implant for spinal fusion. "Aurora is changing spine surgery, and we are thrilled to receive FDA clearance with the ZIP 51, another key product in the Auro
11/18/14 - Bio-Rad Receives Premarket Application Approval for Its Geenius HIV 1/2 Supplemental Assay
Bio-Rad Laboratories, Inc. and, a global provider of life science research and clinical diagnostic products life science research and clinical diagnostic products, today announced that it has received Premarket Application approval from the U.S. Food and Drug Administration for Bio-Rad's Geenius? HIV 1/ 2 Supplemental Assay. "Bio-Rad is pleased
11/18/14 - Elekta's Clarity Soft Tissue Visualization System Cleared for Use for Cancer Patients In China
By a News Reporter-Staff News Editor at China Weekly News Men with prostate cancer will be the first group of patients inChina to benefit from the recent clearance of Elekta's Clarity? soft tissue visualization system by the China Food and Drug Administration. "As radiation oncology equipment becomes increasingly available to Chinese clinician
11/18/14 - FDA approves Roche's Avastin plus chemotherapy to treat women with platinum-resistant recurrent ovarian cancer
ENP Newswire- 18 November 2014. Release date- 17112014- Roche, today announced that the U.S. Food and Drug Administration approved Avastin in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.1. The approval was based on results from the Phase III AURELIA study that showed Avastin plus chemot
11/18/14 - FDA approves trade name Auryxia for Keryx's ferric citrate [EMBIN (Emerging Markets Business Information News]
The US Food and Drug Administration has approved the trade name Auryxia for Keryx Biopharmaceuticals' FDA- approved ferric citrate. In September 2014, Auryxia was approved by the FDA to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Keryx chief executive officer Ron Bentsur said: We are excited to receive FDA a
11/18/14 - IlluminOss Medical Announces Conditional FDA Approval for Clinical Trials of Groundbreaking Photodynamic Bone Stabilization System in the U.S.
IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received conditional approval from the FDA to conduct a clinical trial for the treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma.
11/18/14 - Switzerland : FDA approves Roche s Avastin plus chemotherapy to treat women with platinum-resistant recurrent ovarian cancer [TendersInfo (India)]
Roche, today announced that the U.S. Food and Drug Administration approved Avastin in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.
11/17/14 - BASF welcomes the passage of the Sunscreen Innovation Act by the House of Representatives; House of Representatives approves bill to reform process for approving new sunscreen ingredients
"As a member of the Public Access to Sun Screens Coalition, BASF highly welcomes the Sunscreen Innovation Act. Passage of the bill represents a significant step towards ensuring the timely review of new sun protection ingredients by the FDA, that will ultimately provide US consumers with a wider array of safe and effective sunscreen products, "said
11/17/14 - BrainStorm Announces Financial Results For The Third Quarter Of 2014 And Provides Corporate Update [Global Data Point]
We added a second site to our phase 2 ALS study and received FDA clearance for manufacturing at our third site, and enrollment has moved along as planned. Also in the quarter, the FDA granted Fast Track designation to NurOwn? in ALS, which will allow us to work with the FDA toward approval of our therapy in the most expeditious manner possible. I
11/17/14 - Covidien's HawkOne? Directional Atherectomy System Receives FDA 510K Clearance for the Treatment of Peripheral Arterial Disease
By a News Reporter-Staff News Editor at Pharma Business Week Covidien plc announced U.S. Food and Drug Administration 510 clearance for the HawkOne? directional atherectomy system. The latest addition to Covidien's directional atherectomy portfolio, the HawkOne? system provides physicians with an enhanced cutting mechanism to more effectively
11/17/14 - FDA Approves Genentech Medicine for Women with Platinum-Resistant Recurrent Ovarian Cancer; Avastin Plus Chemotherapy Reduced the Risk of the Disease Worsening by 62 Percent Compared to Chemotherapy Alone in a Phase III Study
ENP Newswire- 17 November 2014. Release date- 14112014- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration approved Avastin in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer. The approval was based on results from the Phase III AURELIA study
11/17/14 - FDA Okays Sanofi's Lemtrada For Treatment Of Multiple Sclerosis
PARIS- French drug maker Sanofi and its subsidiary Genzyme announced that the U.S. Food and Drug Administration or FDA approved Lemtrada or alemtuzumab for the treatment of patients with relapsing forms of multiple sclerosis or MS. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequat
11/17/14 - Ipsen Announces FDA Approval of a New Delivery Device for Somatuline Depot lanreotide Injection
By a News Reporter-Staff News Editor at Pharma Business Week Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen, announced that the U.S. Food and Drug Administration has approved a new device to deliver Somatuline Depot . According to the Centers for Disease Control and Prevention, each year 385,000 needlestick and sharps-related injuries
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