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 The leading web portal for pharmacy resources, news, education and careers May 4, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 4, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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5/2/16 - Perrigo Announces FDA Approval and Launch of the Generic Version of BenzaClin Pump Topical Gel
Perrigo Company plc today announced it has received final U.S. Food and Drug Administration approval for the generic version of Valeant Pharmaceutical International, Inc.' s BenzaClin Pump Topical Gel. Perrigo' s Chief Executive Officer John T. Hendrickson stated, "This Rx product approval and launch demonstrates the team's ability to leverage
5/2/16 - St. Jude Medical Announces Launch and First US Implants of MultiPoint Pacing Technology
By a News Reporter-Staff News Editor at Clinical Trials Week St. Jude Medical, Inc., a global medical device company, recently received U.S. Food and Drug Administration approval of the company's proprietary, first-to-market MultiPoint? Pacing technology and announced the U.S. launch and first U.S. implants of the Quadra Assura MP? cardiac re
5/2/16 - Synaptive Medical Receives FDA Clearance for Health Informatics Platform
Synaptive Medical Inc., is pleased to announce the Food and Drug Administration clearance of ImageDrive? Pro, an informatics platform designed to seamlessly integrate their existing BrightMatter? technologies. The massive challenge in achieving the goal of precision medicine is a standardized approach to capturing data on a health informatics p
5/2/16 - Toshiba's Aquilion Lightning CT Receives FDA Clearance with More Powerful Generator
By a News Reporter-Staff News Editor at Cardiovascular Week Providers can now image a wider range of patients with a low cost of ownership as Toshiba America Medical Systems, Inc.' s AquilionTM Lightning was FDA cleared with a more powerful 50- kW generator. "Toshiba CT puts customers first by providing top-tier solutions on every scanner, inclu
5/2/16 - ZEMBRACE? SymTouch? Sumatriptan Injection 3 mg, Approved by the FDA in January 2016 for the Acute Treatment of Migraine with or without Aura in...
ZEMBRACE? SymTouch? Sumatriptan Injection 3 mg, Approved by the FDA in January 2016 for the Acute Treatment of Migraine with or without Aura in Adults, is Now Commercially Available in the U.S.. By a News Reporter-Staff News Editor at Pharma Business Week Promius Pharma LLC, a subsidiary of Dr. Reddy's Laboratories, announced that ZEMBRACE Sy
4/30/16 - CNOGA Receives CFDA Approval for Marketing in China of Non Invasive Multiple Bio Parameters Monitors
By a News Reporter-Staff News Editor at Marketing Weekly News CNOGA Medical Ltd., a developer and manufacturer of medical devices, announces that it has received an approval for its TensorTip? MTX? and VSM? non-invasive multiple bio parameters measurement devices from the China Food and Drug Administration. Dr. Segman added; " China is the
4/30/16 - United States : FDA approves first generic Crestor [TendersInfo (India)]
The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments, said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDAs Center for Drug Evaluation and Research. The FDA requires that generic drugs meet rigorous scientific and quality standards.
4/29/16 - European Medicines Agency Issues Positive Opinion for the Use of IMBRUVICA (ibrutinib) as a First-Line Treatment for Chronic Lymphocytic Leukemia Patients
AbbVie, a global biopharmaceutical company, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion in favor of the use of IMBRUVICA for the treatment of adult patients with previously-untreated chronic lymphocytic leukemia in the European Union. IMBRUVICA is jointly...
4/29/16 - FDA Approves ACADIA Pharmaceuticals NUPLAZID? (pimavanserin) - The First Drug Approved for the Treatment of Hallucinations and Delusions Associated with Parkinson's Disease Psychosis
ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced that the U.S. Food and Drug Administration has approved NUPLAZID for the treatment of hallucinations and delusions associated with...
4/29/16 - FDA approves Bayer's Gadavist (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries
For U.S. media only Bayer announced today that the U.S. Food and Drug Administration has approved Gadavist injection for use with magnetic resonance angiography to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients. 1 The FDA approval is based on the results of two, multi-center, Phase 3, open-la
4/29/16 - FDA approves first generic Crestor
"The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments," said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "The FDA requires that generic drugs meet rigorous scientific and quality standa
4/29/16 - Teva Announces FDA Approval of ProAir RespiClick (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11
JERUSALEM Teva Pharmaceutical Industries Ltd., announced today that the U.S. Food and Drug Administration has approved ProAir RespiClick Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
4/29/16 - Teva: FDA Approves ProAir Inhalation Powder For Pediatric Asthma Patients
PETAH TIKVA- Teva Pharmaceutical Industries Ltd. announced the U.S. FDA has approved ProAir RespiClick Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
4/28/16 - AbbVie Receives FDA Accelerated Approval of Venclexta venetoclax Tablets, the First BCL-2 Inhibitor in Relapsed/Refractory Chronic Lymphocytic...
By a News Reporter-Staff News Editor at Politics& Government Business AbbVie, a global biopharmaceutical company, announced the U.S. Food and Drug Administration has granted accelerated approval of Venclexta? tablets for patients diagnosed with chronic lymphocytic leukemia with 17 p deletion, as detected by an FDA- approved test, who have recei
4/28/16 - AUROBINDO GETS USFDA NOD FOR 2 GENERICS
Aurobindo Pharma Ltd has obtained the approval of the US Food and Drug. Administration to manufacture and market Oxymorphone hydrochloride tablets. The drug is the bio-equivalent and therapeutic equivalent of Opana of Endo Pharmaceuticals.
4/28/16 - Diadexus, Inc. Reports First Quarter 2016 Financial Results
Diadexus, Inc., a diagnostics company developing and commercializing products that aid in the prediction of cardiac disease risk, today announced financial results for the first quarter ended March 31, 2016 and provided an update on its business. Over the past year, we have successfully broadened and diversified our lab customer base as we work tow
4/28/16 - Immune Therapeutics Receives NAFDAC Approval for Lodonal(TM) in Nigeria: Approval Follows Successful Recent Bridging Study
ORLANDO, Fla.- April 27, 2016- Immune Therapeutics, Inc., a clinical-stage biotech company providing immunotherapy solutions for the treatment of autoimmune disease and cancer with a focus on emerging nations, today announced that Nigeria's National Agency for Food and Drug Administration and Control has approved its patented Lodonal as an over the
4/28/16 - KERYX BIOPHARMACEUTICALS INC - 10-Q - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Our product, Auryxia, also known as Riona in Japan and Fexeric in Europe, is an oral, absorbable iron-based medicine, that received marketing approval from the U.S. Food and Drug Administration, or FDA, in September 2014 for the control of serum phosphorus levels in patients with chronic kidney disease, or CKD, on dialysis. When discussing ferric c
4/28/16 - Neovacs obtains FDA approvalto extend its Phase IIb clinical trial in Lupus to United States
Neovacs a leader in active immunotherapy for the treatment of autoimmune diseases, today announced that the Company has received the approval Investigational New Drug, from the Food and Drug Administration, to extend its ongoing Phase IIb clinical trial of IFN Kinoid for the treatment of Lupus to the United States.. Miguel Sieler, CEO of
4/28/16 - Taking stock: Cumberland clinical pipeline, Quorum stock index
Cumberland Pharmaceuticals executives have received Food and Drug Administration approval to begin a Phase II clinical program for a new oral treatment for patients with the autoimmune disease scleroderma. Vasculan is the third treatment Cumberland is developing from the ifetroban compound it acquired along with Vanderbilt University in 2011..
4/27/16 - FDA Clears Ultra-High-Frequency Ultrasound System
Fujifilm SonoSite subsidiary Fujifilm VisualSonics has received FDA 510(k) clearance for its Vevo MD ultra-high-frequency ultrasound system. Designed for vascular, musculoskeletal, dermatological, and neonatological applications, the Vevo MD enables clinicians to visualize anatomy within the first 3 cm of the body.
4/27/16 - Ipsen is pleased to announce that its partner Exelixis obtained FDA Approval of CABOMETYX
Release date- 26042016- Paris- Ipsen is pleased to announce that its partner Exelixis, Inc. received approval from the U.S. Food and Drug Administration for CABOMETYX tablets earlier today for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. On February 29, 2016, Exelixis and Ipsen jointl
4/27/16 - Siemens Brain MRI Appliances Receive FDA Clearance
The FDA has cleared Siemens Healthcare's new GOBrain and Simultaneous Multi-Slice (SMS) MRI applications, which are designed to reduce the time it takes to perform MRI brain exams. The SMS application reduces the time to acquire 2D MR images by as much as eight times.
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