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 The leading web portal for pharmacy resources, news, education and careers October 20, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - October 20, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 48     Next >>     Go To Page:

10/20/18 - HeartMate 3 gets FDA approval for extended use [Star Tribune (Minneapolis)]
Oct. 20 There are more people in need of new hearts than there are hearts available that's a big reason companies like Abbott Laboratories and Medtronic sell advanced implantable pumps called left-ventricular assist devices to circulate a person's blood when their heart can't do the job alone. On Friday, Illinois- based Abbott Labs announced th
10/19/18 - Amneal Announces Approval of Carmustine for Injection USP, 100 mg/vial - Preparing for Launch
Amneal Pharmaceuticals, Inc., today announced that it has received FDA approval for a generic version of BiCNU for injection, 100 mg. About Amneal Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is an integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar
10/19/18 - Amneal Announces the Approval and Launch of Generic Isoproterenol Hydrochloride Injection USP
Amneal Pharmaceuticals, Inc., today announced that it has received FDA approval for a generic version of Isuprel TM Injection USP, 0.2 mg/mL and 1 mg/5 mL Single-Dose Vials. About Amneal Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is an integrated specialty pharmaceutical company focused on developing, manufacturing and distri
10/19/18 - Canon Medical Showcases FDA-Cleared Aquilion Precision at ASTRO 2018
At this year s American Society of Radiation Oncology annual meeting in San Antonio, Texas, October 21-24, 2018, Canon Medical Systems USA, Inc. will showcase its recently FDA- cleared Aquilion Precision TM, the world s first Ultra-High Resolution CT system. The Aquilion Precision sets a new bar for CT imaging, said Dominic Smith, senio
10/19/18 - FDA Approves Asthma Indication for Dupixent (dupilumab)
TARRYTOWN, N.Y. and PARIS, Oct. 19, 2018/ PRNewswire/. Regeneron Pharmaceuticals, Inc. and Sanofi today announced the U.S. Food and Drug Administration has approved Dupixent as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent as
10/19/18 - FDA approves asthsma indication for Dupixent (dupilumab)
PARIS and TARRYTOWN, N.Y., Oct. 19, 2018/ PRNewswire/ Sanofi. "Dupixent is now approved in the U.S. for two important groups of uncontrolled asthma patients those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientifi
10/19/18 - FDA Approves Label Update for Genentech's Rituxan (Rituximab) in Two Rare Forms of Vasculitis
Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration has approved an update to the Rituxan label to include information on follow up treatment of adult patients with Granulomatosis with Polyangiitis and Microscopic Polyangiitis who have achieved disease control with induction treatment.
10/19/18 - FDA Panel OKs Tegaserod for IBS With Constipation in Women With Low CV Risk [Sport360]
The Gastrointestinal Drugs Advisory Committee of the US Food and Drug Administration voted overwhelmingly to recommend reintroducing tegaserod maleate for the treatment of irritable bowel syndrome with constipation in women without a history of cardiovascular ischemic disease and who have no more than one risk factor for CV disease.
10/19/18 - OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 26th Surgical System
OrthoPediatrics Corp., a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510 clearance from the U.S. Food and Drug Administration for its new RESPONSE 4.5/ 5.0 mm System for treating smaller stature younger patients with complex scoliosis. Scott Luhmann, M.D., Chief of Staff at Shriners
10/19/18 - Sanofi: FDA approves asthma indication for Dupixent (dupilumab)
Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype Only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype Only asthma biologic that offers patient self-administration at home Only asthma biologic also approved for adult patients with moderate-to-severe atopic...
10/19/18 - Super-Potent Opioid Medication Will Be Abused and Kill People, Shouldn't Be Approved, Warns FDA Advisory Committee Chair
In a highly unusual move, the chair of a U.S. Food and Drug Administration advisory committee is bucking his committee's recommendation and publicly warning that a proposed new opioid medication would be abused and start killing people as soon as it hits the market. Raeford Brown, chair of the FDA's Anesthetic and Analgesic Drug Products Advisory C
10/19/18 - Zydus Cadila gets USFDA nod for generic gout attacks drug [Tehran Times (Iran)]
Drug firm Zydus Cadila Thursday said it has received a tentative nod to market generic Colchicine tablets used for prevention and treatment of gout attacks in US market. The company has received the tentative approval from the United States Food and Drug Administration to market Colchicine tablets USP in the strength of 0.6 mg, Zydus Cadila said in
10/18/18 - Abbott Reports Third-Quarter 2018 Results
Abbott narrowed its full-year 2018 diluted EPS guidance range from continuing operations on a GAAP basis to $1.33 to $1.35 and adjusted diluted EPS from continuing operations to $2.87 to $2.89. In the U.S., Abbott received FDA approval of its FreeStyle Libre 14 day sensor, making it the longest lasting wearable glucose sensor available. In July, Ab
10/18/18 - Breckenridge Announces Final Approval of its ANDA for Roflumilast Tablets Daliresp
By a News Reporter-Staff News Editor at Drug Week Breckenridge Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Roflumilast Tablets, 500 mcg, generic for Daliresp Tablets by AstraZeneca Pharmaceutical LP. Breckenridge's Roflumilast Tablets product
10/18/18 - Cadila gets USFDA approval to market Clobetasol Propionate Crea [Sudan Tribune]
Zydus Cadila has received approval from the US Food and Drug Administration to market Clobetasol Propionate Cream,, 0.05%, the company said in a press note to the exchanges on Wednesday. Cadila Healthcare share price is currently trading at Rs376.55, down Rs4.2, or 1.1%, from its previous close of Rs380.75 on the BSE. It has touched a high and low
10/18/18 - Centric Medical? Announces 510(k) Clearance of the SATURN? External Fixation System
Centric Medical, a division of Life Spine , Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today That the U.S. Food and Drug Administration has given 510 marketing clearance to the SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and c
10/18/18 - FDA Approves Stiolto Respimat Supplemental New Drug Application sNDA to Add Data on COPD Exacerbation Reduction
By a News Reporter-Staff News Editor at Pharma Business Week Boehringer Ingelheim announced that the U.S. Food and Drug Administration approved new labeling for Stiolto Respimat Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium, which is the active ingredient in Spiriva Respimat Inhalati
10/18/18 - FDA Approves Yutiq to Treat Chronic Noninfectious Uveitis [Tehran Times (Iran)]
The FDA approved Yutiq for the treatment of chronic noninfectious uveitis, which affects the posterior part of the eye. The company plans to launch the drug in the first quarter of 2019.. In two randomized, sham injection-controlled, double-masked phase 3 clinical trials, YUTIQ significantly reduced recurrent uveitis flares compared to the sham.
10/18/18 - Findings from Duke University Update Knowledge of Gender Health [Gender and Ethnicity of Enrolled Participants in US Food and Drug Administration (FDA) Clinical Trials for Approved Ophthalmological New Molecular Entities]
By a News Reporter-Staff News Editor at Women's Health Weekly Data detailed on Gender and Health- Gender Health have been presented. For more information on this research see: Gender and Ethnicity of Enrolled Participants in US Food and Drug Administration Clinical Trials for Approved Ophthalmological New Molecular Entities. Journal of the Nation
10/18/18 - Pfizers Talzenna PARP breast cancer drug approved in US [T-break Tech (Middle East)]
The US drug regulator has approved Pfizers breast cancer medicine Talzenna for patients with a certain mutation. The drug was approved by the US Food and Drug Administration for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2negative locally advanced or metastatic breast cancer. Jennifer Litton, lead investigator and.
10/18/18 - VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination
Viseon, Inc. today announced that it has received 510 clearance from the U.S. Food and Drug Administration for their Voyant System for Minimally Invasive Spine Surgery, featuring proprietary HD imaging sensor and illumination technology. John Liu, MD, professor of clinical neurological surgery at the Keck School of Medicine of USC commented, Thi
10/17/18 - AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA (ibrutinib) in Combination with Obinutuzumab (GAZYVA) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
AbbVie, a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for Priority Review for IMBRUVICA in combination with obinutuzumab in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
10/17/18 - AzurRx BioPharma Announces FDA Acceptance of IND Application for Phase 2 Clinical Trial of MS1819-SD in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
NEW YORK- AzurRx BioPharma, Inc., a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that the United States Food and Drug Administration has cleared its Investigational New Drug application for the Company's lead asset, MS1819-SD, in patients with exocrine pancreatic...
10/17/18 - EyePoint Pharmaceuticals Receives FDA Approval of YUTIQ 0.18 mg
WATERTOWN- EyePoint Pharmaceuticals, Inc., a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced today that the U. S. Food and Drug Administration has approved YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
10/17/18 - FDA approves generic EpiPen
The Food and Drug Administration in August approved the first generic version of EpiPen, providing new competition that could help drive down the cost of a lifesaving product that had become a notorious symbol of high drug prices. The generic copy is made by Teva Pharmaceuticals USA, and will rival Mylan, which had come under intense criticism for
Articles(s): 1 - 25 of 48     Next >>     Go To Page:


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