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 The leading web portal for pharmacy resources, news, education and careers May 6, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 6, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 43     Next >>     Go To Page:

5/5/16 - Crospon Receives Expanded Indications from FDA for EndoFLIP Catheter
GALWAY, Ireland Crospon has today announced that it has received clearance from the US FDA for expanded indications of use for its EndoFLIP endolumenal imaging system. The US Centers for Medicare and Medicaid Services have begun providing payments for the use of EndoFLIP in the esophagus under the current procedure terminology code 91040,
5/5/16 - Hikma receives FDA approval for Fluphenazine Decanoate Injection
Release date- 04052016- London- Hikma Pharmaceuticals PLC,, the fast growing multinational pharmaceutical group, announces that its supplemental Abbreviated New Drug Application for Fluphenazine Decanoate Injection USP, 125 mg/5 mL multiple-dose vial has been approved by the U.S. Food and Drug Administration. Hikma operates through three businesses
5/5/16 - Hikma receives FDA approval for Leucovorin Calcium Injection
Release date- 04052016- London- Hikma Pharmaceuticals PLC,, the fast growing multinational pharmaceutical group, announces that its supplemental Abbreviated New Drug Application for Leucovorin Calcium Injection, 350 mg Single-use vial has been approved by the U.S. Food and Drug Administration. Hikma operates through three businesses:' Injectables',
5/5/16 - PharmaCyte Biotech Clears Major Milestone on Path to FDA Clinical Trial
PharmaCyte Biotech has now reached a point in its life cycle where it is ready to start working with the U.S. FDA to get the company's Phase 2 b clinical trial in advanced pancreatic cancer underway. These are truly exciting times at PharmaCyte, and with the cell encapsulation facility now cGMP-compliant, the company can set its sights on first req
5/5/16 - United States : Boston Scientific announces U.S. FDA approval of navigation-enabled ablation catheters [TendersInfo (India)]
Boston Scientific has received U.S. Food and Drug Administration approval for two catheters that can be used with the Rhythmia Mapping System. These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market. "By combining these new magnetic navigation-enabled catheters with our high-density, high-resolution.
5/4/16 - Alembic Pharma tumbles 2% despite FDA go-ahead for partial onset seizures drug [India Infoline News Service]
Shares of Alembic Pharma closed 1.59% lower at Rs. 593.30 on BSE after the company received USFDA's approval for partial onset seizures drug. The company has received final approval from the US Food& Drug Administration for its Abbreviated New Drug Application for Lacosamide Tablets, SO mg, 100 mg, lSO mg and 200 mg.The approved ANDA is therapeut
5/4/16 - ICAD Reports First Quarter 2016 Financial Results [Global Data Point]
?Launched breast tomosynthesis cancer detection software solution at the European Congress of Radiology meeting in March; received CE Mark and submitted final premarket approval module for U.S. Food and Drug Administration approval in April? Introduced SMART platform and software solution with extended-life X-ray source for Xoft Axxent ...
5/4/16 - Marksans Pharma ends 10% higher on FDA nod for diabetes drug [India Infoline News Service]
Shares of Marksans Pharma ended 9.84% lower at Rs. 50.25 on BSE after the company announced that it has received USFDA nod for a type 2 diabetes drug. The company announced that USFDA has granted approval for an Abbreviated New Drug Application for Metformin Hydrochloride Extended Release Tablets USP 500 mg and 750 mg. Metformin Hydrochloride ER
5/4/16 - VenclextaTM venetoclax Approved for Chronic Lymphocytic Leukemia, Available at Biologics, Inc.
By a News Reporter-Staff News Editor at Biotech Week Biologics, Inc. is pleased to announce the company has been selected by AbbVie Inc. to be a specialty pharmacy provider for VenclextaTM. Approved by the U.S. Food and Drug Administration on April 11, 2016, Venclexta is indicated for the treatment of patients with chronic lymphocytic leukemia wi
5/3/16 - ALEMBIC GETS USFDA NOD FOR SEIZURES DRUG
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its abbreviated new drug application for lacosamide tablets 50 milligrams, 100 mg, 150 mg and 200 mg.
5/3/16 - BIOTRONIK Announces FDA Approval of MR Conditional Cardiac Resynchronization Defibrillators
BIOTRONIK, a leader in cardio- and endovascular medical technology, today announced Food and Drug Administration approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging scans. Iperia devices also have remote monitoring with daily automatic.
5/3/16 - Boston Scientific Announces U.S. FDA Approval of Navigation-Enabled Ablation Catheters
Boston Scientific has received U.S. Food and Drug Administration approval for two catheters that can be used with the Rhythmia? Mapping System. These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market. "By combining these new magnetic navigation-enabled catheters with our high-density, high-resolu
5/3/16 - FDA approves Nuplazid to treat hallucinations in Parkinson's disease
The FDA has approved Acadia's Nuplazid, the first drug approved to treat hallucinations and delusions experienced by some people with Parkinson's disease...
5/3/16 - Ireland : Medtronic Receives FDA Approval for New Single-Chamber ICDs That Detect Atrial Fibrillation [TendersInfo (India)]
Medtronic plc today announced it has received U.S. Food and Drug Administration approval for the Visia AF MRI (TM) SureScan and Visia AF (TM) single-chamber implantable cardioverter defibrillators. More than half of all new ICD implants in the U.S. are single-chamber devices. "Approximately 75 percent of ICD patients have no history of atrial fibr
5/3/16 - Medtronic Builds Out MRI-Compatible Platform Further
Release date- 02052016- Medtronic announced Monday that FDA has cleared its MRI- compatible StrataMR valves and shunts that are part of the company's Strata line of Adjustable Valve Systems used in the treatment of patients with hydrocephalus and cerebrospinal fluid disorders. Medtronic's MRI- compatible pacemakers, ICDs, Deep Brain Stimulation sys
5/3/16 - Medtronic Receives FDA Approval for New Single-Chamber ICDs That Detect Atrial Fibrillation
Release date- 02052016- DUBLIN- Medtronic plc today announced it has received U.S. Food and Drug Administration approval for the Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators. More than half of all new ICD implants in the U.S. are single-chamber devices. 'Approximately 75 percent of ICD patients have no h
5/3/16 - RNK in Beta for FDA Cleared Telemedicine Stethoscope Software
RNK Products, Inc. is beta testing a simplified version of its FDA approved sSOIP telemedicine stethoscope software that enables the stethoscope stream to go over the video conferencing audio channel. This signal processing must be FDA cleared as "accessory" elements to the electronic stethoscope itself. If any of the stethoscope signal processing
5/3/16 - Synaptive Medical Receives FDA Clearance for Health Informatics Platform [Palestine Chronicle, The]
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 need for deeper interconnectivity and integration of our own systems and data platforms is essential as we look at introducing novel imagi
5/3/16 - United States : FDA approves Gadavist injection as first contrast agent in U.S. for use with magnetic resonance angiography of supra-aortic arteries [TendersInfo (India)]
The FDA approval is based on the results of two, multi-center, Phase 3, open-label clinical studies the GEMSAV study of patients with known, or suspected vascular disease, of the supra-aortic arteries and the GRAMS study of patients with known or suspected renal artery disease. Elias Melhem, M.D., Chair, Department of Diagnostic Radiology& Nuclear
5/2/16 - Allergan Launches Generic Version Of CRESTOR
LONDON- Allergan plc confirmed it has received approval from the U.S. FDA on its Abbreviated New Drug Application for rosuvastatin calcium 5, 10, 20 and 40 mg tablets, the generic version of AstraZeneca's CRESTOR tablets. Under the agreement with AstraZeneca on March 25, 2013, Allergan has launched its generic version of CRESTOR 67 days prior to Ju
5/2/16 - Allergan Receives FDA Approval and Launches First Generic Version of CRESTOR (rosuvastatin)
Allergan plc, a leading global pharmaceutical company, today confirmed that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for rosuvastatin calcium 5, 10, 20 and 40 mg tablets, the generic version of AstraZeneca's CRESTOR tablets. Following receipt of the FDA approval, Allergan
5/2/16 - Eisai Announces FDA Approval of FYCOMPA (perampanel) Oral Suspension for Adjunctive Therapy in the Treatment of Partial-Onset Seizures and Primary Generalized Tonic-Clonic Seizures
"We are excited about the approval of FYCOMPA Oral Suspension, as it gives another option to patients with epilepsy who may have difficulty swallowing tablets or prefer liquids," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "The development of this new formulation underscores Eisai's co
5/2/16 - 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 standar
5/2/16 - Flamel Technologies Receives FDA Approval of Akovaz(TM)
Flamel obtained NDA approval for Akovaz as scheduled on April 29 and is the first to receive approval from the FDA for ephedrine sulfate. Our ?clat portfolio of products, which includes Bloxiverz and Vaculep , has produced significant cash flow for Flamel, allowing us to operate independently of partners, fund strategic acquisitions and conti
5/2/16 - Hologic Announces FDA Clearance and Commercial Availability of the Affirm Prone Biopsy System, the First 2D/3D Imaging-Guided Dedicated Prone Biopsy...
By a News Reporter-Staff News Editor at Pharma Business Week Hologic, Inc. announced the U.S. Food and Drug Administration clearance and commercial launch of the Affirm? prone biopsy system, the first dedicated prone biopsy system to offer both 2 D and 3 D? imaging-guided breast biopsies. "At Hologic, we challenge ourselves to advance medica
Articles(s): 1 - 25 of 43     Next >>     Go To Page:


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