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 The leading web portal for pharmacy resources, news, education and careers November 27, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 27, 2014

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 - 19 of 19     Go To Page:

11/27/14 - SQI DIAGNOSTICS Receives FDA Clearance for its Ig-plex Celiac DGP Panel for Sale in the United States
By a News Reporter-Staff News Editor at Politics& Government Week SQI Diagnostics Inc. announced that it has received notice that the United States Food and Drug Administration has cleared the Company to market its proprietary Celiac Panel in the United States. "We are very excited to have received FDA clearance," said Andrew Morris, CEO, SQI Di
11/25/14 - Philips receives FDA 510(k) clearance for IQon Spectral CT
Reinforcing its commitment to enabling confident diagnosis through innovation, Royal Philips today announced 510 clearance from the U.S. Food and Drug Administration for its IQon Spectral CT, presenting an entirely new approach to spectral imaging. This first-of-its kind technology adds a new dimension to Computed Tomography imaging, delivering..
11/25/14 - Valeant Pharmaceuticals Announces FDA Approval Of ONEXTON? Gel For The Treatment Of Acne Vulgaris
Valeant Pharmaceuticals International, Inc. announced today that it has received approval from the Food and Drug Administration for ONEXTON? Gel, 1.2%/ 3.75%, for the once-daily treatment of comedonal and inflammatory acne in patients 12 and older. "We are very pleased that the FDA has approved this new dual action medication that gives physic
11/25/14 - Vascular Solutions Receives 510(k) Clearance for Gel-Block 10x Embolization Product
Vascular Solutions, Inc. today announced that it has received 510 clearance from the U.S. Food and Drug Administration for Gel-Block 10 x embolization pledgets for use in the treatment of hypervascular tumors and arteriovenous malformations. Vascular Solutions is launching the product in the U.S. this week. The Gel-Block 10 x version builds on Vasc
11/24/14 - Cepheid Receives FDA Clearance for Xpert Flu/RSV XC
Cepheid today announced it has received clearance from the U.S. Food& Drug Administration to market its Xpert Flu/RSV XC, an on-demand molecular test for accurate and reliable determination of Flu A, Flu B, and differentiation of RSV infection. Xpert Flu/RSV XC runs on Cepheid's GeneXpert System, the world's leading molecular diagnostic pla
11/24/14 - Covidien's Fortrex? PTA Balloon Receives FDA 510(k) Clearance
Covidien plc today announced U.S. Food and Drug Administration 510 clearance for its Fortrex? over-the-wire percutaneous transluminal angioplasty balloon catheter. The Fortrex? 0.035 OTW PTA balloon catheter the next-generation high pressure solution to maintain arteriovenous access is also intended for use in the peripheral vascular s
11/24/14 - FDA Approves New Styles of Allergan's NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
By a News Reporter-Staff News Editor at Pharma Business Week Allergan, Inc. announced that the company has received approval from the U.S. Food and Drug Administration to market two new styles, X and L, of the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and rev
11/24/14 - ImThera Medical, Inc. Receives FDA Approval for Pivotal Study for Obstructive Sleep Apnea Device
By a News Reporter-Staff News Editor at Clinical Trials Week ImThera Medical, Inc., a privately held global medical device company, announced that the U.S. Food and Drug Administration has approved an investigational device exemption for its THN3 Clinical Study. "This is the most exciting innovation for the treatment of sleep apnea since CPAP,"
11/24/14 - Par Pharmaceutical Announces First FDA Approval of Vasostrict? vasopressin injection, USP
By a News Reporter-Staff News Editor at Pharma Business Week Par Pharmaceutical Companies, Inc. announced that it has received approval for its New Drug Application for Vasostrict 20 units/mL from the U.S. Food and Drug Administration pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act. Par's Vasostrict is the first and only vasop
11/24/14 - U.S. FDA Approves Supplemental New Drug Applications for Once-Monthly Long-Acting Therapy INVEGA SUSTENNA paliperidone palmitate for the Treatment...
By a News Reporter-Staff News Editor at Clinical Trials Week Janssen Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration approved the supplemental New Drug Applications for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA to treat schizoaffective disorder as either monotherapy or adjunctive therapy.
11/22/14 - United States : FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties [TendersInfo (India)]
Hysingla ER has approved labeling describing the product s abuse-deterrent properties consistentwith the FDA s 2013 draft guidance for industry, Abuse-Deterrent Opioids Evaluation and Labeling. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult. While the science of a
11/21/14 - Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture;...
SUMMARY: The Food and Drug Administration is announcing the availability of a document entitled "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry" dated December 2014. The guidance announced in this notice finalizes the draft guidance
11/21/14 - EDDA Technology Introduces the Newly FDA-Cleared IQQA-BodyImaging and Cloud-Based OnDemand Services for Imaging-Guided Cancer Treatment
EDDA Technology, a global leading provider in advanced real-time interactive quantitative imaging solutions, announced today that the company has received FDA clearance on IQQA - BodyImaging. The new product will be introduced as the latest addition to the IQQA Platform and Product Suite for imaging-guided cancer treatment at the 100 th Scie
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 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.
11/20/14 - Kubtec Announces FDA Approval of the Highest Resolution Low Dose Portable Digital Radiography System for NICU
Kubtec, the foremost developer of low dose digital radiography systems, today announced FDA approval of the KUB 250, the first truly portable low-dose digital X-ray system dedicated to the neonatal intensive care unit. "The KUB 250 has been clinically tested to reduce radiation exposure by up to 40% with our advanced high resolution imaging tech
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.
Articles(s): 1 - 19 of 19     Go To Page:


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