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 The leading web portal for pharmacy resources, news, education and careers October 20, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - October 20, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 83     Next >>     Go To Page:

10/20/14 - BioDelivery Sciences to Provide BUNAVAIL Launch Update
By a News Reporter-Staff News Editor at Pharma Business Week BioDelivery Sciences International, Inc. will host an investor update conference call and webcast to discuss the launch of BUNAVAIL? buccal film which has been approved by the U.S. Food and Drug Administration for the maintenance treatment of opioid dependence. Since FDA approval of B
10/20/14 - Boehringer Ingelheim's OFEV Approved by FDA as a Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis [Professional Services Close - Up]
Boehringer Ingelheim Pharmaceuticals, Inc. reported that the U.S. Food and Drug Administration approved OFEV capsules for oral use for the treatment of idiopathic pulmonary fibrosis. According to a release from the Company, granted Breakthrough Therapy designation during its review by the FDA, OFEV, capsules for oral use, taken twice daily, is the
10/20/14 - FDA Approves Dexcom SHARE?, the First Remote Mobile Communications Device Used for Continuous Glucose Monitoring (CGM)
Dexcom, Inc., a leader in continuous glucose monitoring for patients with diabetes, announced today that it has received U.S. Food and Drug Administration approval for its CGM remote mobile communications device: Dexcom SHARE. Dexcom SHARE represents a significant advance in diabetes care by allowing people with diabetes to share important gluco
10/20/14 - Halozyme Receives FDA Approval For Additional Manufacturing Facilities For Hylenex Recombinant
Halozyme Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has approved new contract manufacturing facilities used in the production of Hylenex recombinant. The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in H
10/20/14 - Medical marijuana debate focuses on what is an approved drug, and language of proposed amendment [Naples Daily News, Fla.]
Oct. 20 NAPLES Voters will consider making Florida the 24th state and the first in the South to approve a comprehensive medical marijuana program, but opponents argue a synthetic form of marijuana already offers medical relief that's controlled by the Food and Drug Administration. The debate over medical marijuana in Florida has raged between s
10/20/14 - Neovasc Receives FDA Conditional Approval to Initiate TIARA-I Trial in US: A Multinational, Multicenter Early Feasibility Trial of the Tiara?...
By a News Reporter-Staff News Editor at Pharma Business Week Neovasc Inc. announced that it has received conditional Investigational Device Exemption approval from the U.S. Food and Drug Administration to initiate the U.S. arm of its TIARA-I Early Feasibility Trial for the Company's Tiara? transcatheter mitral valve. "We are delighted that aft
10/20/14 - OssDsign's Cranioplug receives marketing approval in the US
OssDsign AB today announced that its bioceramic burr hole plug- Cranioplug- has received 510 clearance by the US Food and Drug Administration. The clearance from the FDA demonstrates OssDsign can effectively navigate the FDA regulatory process and access the world s largest market. This is a good example of how a management team with a proper bl
10/20/14 - PFIZER -FDA Approves Abuse Deterrent Labeling for EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended-Release (ER) Capsules CII
Release date- 17102014- Pfizer Inc. announced today that the United States Food and Drug Administration has approved an updated label for EMBEDA extended-release capsules, for oral use, CII, to include abuse-deterrence studies. Pfizer expects EMBEDA will be available in the U.S. in early 2015.. However, misuse and abuse of opioids in the U.S. is a
10/20/14 - Vesiflo Receives FDA Approval for inFlow Urinary Prosthesis Device for Women [Health & Beauty Close - Up]
Vesiflo reported that its Direct De Novo Petition for the inFlow Urinary Prosthesis has been granted by the U.S. Food and Drug Administration, allowing the inFlow to be freely marketed in the U.S. According to a release from the company, the inFlow is a non- surgical device that provides a convenient and dignified alternative to urinary catheters.
10/19/14 - AnthroTronix Receives FDA Clearance for Brain Health Assessment Tool [EMBIN (Emerging Markets Business Information News]
? ?We are pleased that DANA has sought and received FDA clearance, leading the way for this type of game-changing technology, ? said Corinna Lathan, founder and CEO of AnthroTronix. ? ?In essence, measuring reaction time is like taking the temperature of the brain? like a' Brain Thermometer'? and it is a vital par
10/19/14 - FDA Clears Vivolux to Proceed with VLX1570 to Clinical Phase I/II for Treatment Against Relapsed and/or Refractory Multiple Myeloma [Professional Services Close - Up]
Vivolux reported that the FDA recently granted clearance to proceed with VLX1570 to clinical phase I/II for treatment against relapsed and/or refractory multiple myeloma. Vivolux said that the clinical study will be conducted in collaboration with the Memorial Sloan-Kettering Cancer Center and the Dana-Farber Cancer Institute at Harvard Medical...
10/19/14 - FDA OKs Eylea (aflibercept) Injection [Professional Services Close - Up]
Regeneron Pharmaceuticals said that the U.S. Food and Drug Administration has approved Eylea Injection for the treatment of Macular Edema following Retinal Vein Occlusion, which includes Macular Edema following Branch Retinal Vein Occlusion in addition to the previously-approved indication of Macular Edema following Central Retinal Vein Occlusion.
10/19/14 - United States : FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic [TendersInfo (India)]
The U.S. Food and Drug Administration today approved new labeling for Embeda extended-release capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is the third ER opioid analgesic to be approved with labeling descri
10/18/14 - Diplomat: Otezla Gets FDA Approval for Treatment of Plaque Psoriasis [Professional Services Close - Up]
Diplomat reported that Otezla has been granted expanded approval by the U.S. Food and Drug Administration for the treatment of moderate to severe plaque psoriasis. Otezla is an oral small-molecule inhibitor of phosphodiesterase 4, or PDE4, specific for cyclic adenosine monophosphate. According to a media release, Diplomat is a member of a limited p
10/18/14 - Esaote Gets FDA Clearance for Its Portable MyLab Gamma Ultrasound System [Professional Services Close - Up]
Esaote North America reported that its new MyLab Gamma ultrasound system has received 510 clearance from the U.S. Food and Drug Administration and is now available for sale in the United States. "Today's practices are under increasing pressure to deliver quality healthcare at an affordable cost," said Larry Dentice, president and general manager o
10/18/14 - FDA Approves B. Braun Injection Containers [Manufacturing Close - Up]
B. Braun Medical reported that it recently received FDA approval of Sterile Water for Injection USP in 2 L and 3 L containers. According to a company release, these pharmacy bulk package new products will be used with B.Braun' s Pinnacle TPN Management System and other automated compounding devices. "B.Braun is committed to growing its clinical nu
10/18/14 - JayMac Pharmaceuticals Releases Case Study: Treating Teen Depression With EnLyte
There is only one drug FDA approved for use in this group, Prozac/Fluoxetine, and it comes with common SSRI side effect warnings: nausea, headaches, anxiety, insomnia, drowsiness, and loss of appetite, as well as withdrawal reactions such nausea, nervousness, and insomnia when the drug is stopped. According to Dr. Farah, "We finally have an agent t
10/18/14 - National Recognized Gynecologic Oncologist Dr. Dwight Im World's First to Perform Surgery Using New FDA Cleared Single Site Wristed Needle Driver Technology
Dwight D. Im, M.D., FACOG, Director of The Gynecologic Oncology Center at Mercy and The National Institute of Robotic Surgery at Mercy in Baltimore, became the first surgeon in the world to successfully perform a minimally-invasive hysterectomy via robotic surgery using the new Single-Site Wristed Needle Driver, developed by Intuitive Surgical, Inc
10/17/14 - Anti-abuse label approved for painkiller Embeda
The FDA said Friday that Pfizer Inc.' s Embeda can have labeling indicating that it has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted. The FDA has been under intense public pressure to combat the national epidemic of prescription opioid abuse. Embeda is the third extended-release opioid to be approve
10/17/14 - Boehringer Ingelheim's OFEV (nintedanib*) approved by the FDA for the treatment of idiopathic pulmonary fibrosis
Release date- 16102014- Ingelheim, Germany,- Boehringer Ingelheim announced today that the US Food and Drug Administration has approved OFEV for the treatment of idiopathic pulmonary fibrosis, a debilitating and fatal lung disease, which has a median survival of 2-3 years after diagnosis.2. Until today there were no FDA- approved treatments for IPF
10/17/14 - Bracco Diagnostics Gets FDA Approval for New Ultrasound Contrast Agent [Health & Beauty Close - Up]
Bracco Diagnostics said that the U.S. Food and Drug Administration has approved its new ultrasound contrast agent Lumason for injectable suspension, indicated for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Bracco said that Lumason h
10/17/14 - Chimerix gets FDA OK to test drug for Ebola
Chimerix Inc. said Thursday that it has received FDA clearance to proceed with a trial examining the safety and effectiveness of its brincidofovir tablets in patients who have the virus. Chimerix did not immediately return requests for comment. Chimerix is working with the U.S. Department of Defense on developing the drug as a treatment against sma
10/17/14 - Chimerix gets US OK to test drug for Ebola
Chimerix Inc. said Thursday that it has received FDA clearance to proceed with a trial examining the safety and effectiveness of its brincidofovir tablets in patients who have the virus. With FDA's permission, the North Carolina drugmaker previously made the drug available to the first Ebola patient diagnosed in the U.S., who died in Dallas last we
10/17/14 - China Biologic Receives Approval for Commercial Manufacturing of Human Prothrombin Complex Concentrate at Shandong Taibang Facility
China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company has received approval from the China Food and Drug Administration for commercial manufacturing of human prothrombin complex concentrate at its Shandong Taibang facility. David Gao, Chairman and Chief Executiv
10/17/14 - Clinical Innovations Gets FDA Approval for Koala Toco [Manufacturing Close - Up]
Clinical Innovations reported that the FDA approved Koala Toco, a tocodynamometer to utilize air-charged technology to measure uterine contractions. In its release, the Company said that Koala Toco provides "enhanced signal acquisition, easier-to-visualize tracings, and a better overall monitoring experience." It's also convenient to have new, clea
Articles(s): 1 - 25 of 83     Next >>     Go To Page:


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