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 The leading web portal for pharmacy resources, news, education and careers November 28, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 28, 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 - 15 of 15     Go To Page:

11/27/14 - LifeTech Sci's product approved as innovative medical device [ET Net News (China)]
LifeTech Scientific Corporation said it. has recently obtained the final approval from the Center for Medical Device Evaluation of. the China Food and Drug Administration and its iron-based bioresorbable drug-eluting.
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
11/27/14 - Valeant gets FDA approval for ONEXTON gel to treat acne vulgaris [EMBIN (Emerging Markets Business Information News]
Valeant Pharmaceuticals International 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 physicians and patients a new option for th
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
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