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 The leading web portal for pharmacy resources, news, education and careers May 2, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 2, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 67     Next >>     Go To Page:

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
5/2/16 - Lice Clinics of America Opens New Treatment Center on Monterey Peninsula
But thanks to the opening of a new Lice Clinics of America clinic, moms in the Monterey area no longer have to worry about treating the icky bugs themselves. Lice Clinics of America provides screening, diagnosis and treatment options for people infested with head lice. I decided that we have to have a Lice Clinics of America treatment center on the
5/2/16 - Medtronic Receives FDA Approval for New Single-Chamber ICDs That Detect Atrial Fibrillation
Visia AF MRI SureScan and Visia AF ICDs Treat Dangerous Heart Rhythms and Enable Physicians to Identify Patients at Increased Risk for Stroke and Heart Failure Due to AF DUBLIN- May 2, 2016- 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.
5/2/16 - Nevro Receives FDA Approval for New Surgical Leads for the Senza Spinal Cord Stimulation System Delivering HF10 Therapy
By a News Reporter-Staff News Editor at Pharma Business Week Nevro Corp., a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, announced that it has received U.S. Food and Drug Administration approval for its surgical leads, which are specifically designed for use with the Senza
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
Articles(s): 1 - 25 of 67     Next >>     Go To Page:


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