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 The leading web portal for pharmacy resources, news, education and careers August 30, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - August 30, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 37     Next >>     Go To Page:

8/30/15 - Dr. Shawn Garber of New York Bariatric Group Executes Orbera Gastric Balloon Procedure for Non Surgical Weight Loss [Manufacturing Close - Up]
Shawn Garber has successfully implanted the first Orbera intragastric balloon in the Northeast since FDA approval. According to a release, although this procedure has had international success for over 20 years with dramatic weight loss results, the Orbera Gastric Balloon has only just been approved for use in the US by the FDA in the last several
8/29/15 - United States : LUPIN bags FDA approval to market Generic PrilosecCapsules [TendersInfo (India)]
Lupin Limited declared that it has obtained final approval from the United States Food and Drugs Administration to market its Omeprazole Delayed-Release capsules 40 mg, a generic version of AstraZeneca Pharmaceuticals LP Prilosec Delayed-Release capsules. Lupin stated that its Omeprazole Delayed-Release capsules are the AB rated generic equivalent.
8/28/15 - Britain's National Health Service Approves The Use Of Mytrus Technology For Electronic Informed Consent In Clinical Trials [Global Data Point]
Mytrus was also the first electronic informed consent technology approved for use in a clinical trial by the U.S. Food and Drug Administration in 2011. It has since been used by some of the world's largest pharmaceutical companies in about 30 studies and received approvals from other national health authorities, as well as 50 institutional review b
8/28/15 - Sunovion Announces FDA Approval of a New Indication for Aptiom (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures
Sunovion Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration approved the supplemental New Drug Application for Aptiom as monotherapy for the treatment of partial-onset seizures. Previously approved in 2013 by the FDA as adjunctive therapy for partial-onset seizures, APTIOM is the only exclusively once-daily...
8/28/15 - US FDA approves new cholesterol lowering drug of Amgen [Big News Network (United Arab Emirates)]
WASHINGTON- American multinational biopharmaceutical company Amgen has received the US Food and Drug Administration approval for its new cholesterol-lowering medication, Repatha injection, becoming the second drug approved in a new class of drugs known as PCSK9 inhibitors. "We are excited about today's approval of Repatha in the US as patients and
8/28/15 - Veloxis Pharmaceuticals announces financial results for the first six months of 2015 and improves the full year outlook [Jerusalem Post (Israel)]
Veloxis Pharmaceuticals announces financial results for the first six months of 2015 and improves the full year outlook. On 10 July, 2015 Veloxis has received U.S. Food and Drug Administration approval of Envarsus XR for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus.
8/27/15 - Akron medical device company moves into new digs downtown, gets FDA approval for system used during surgery to make cancer tumors more visible [The Akron Beacon Journal]
Aug. 27 Two years after setting up shop in Akron, a company with roots in the Netherlands has won a crucial government hurdle to market its camera system used to locate lymph nodes and make cancer tumors visible during surgery. Quest Medical Imaging Inc. also has graduated from the city's business incubator, the Akron Global Business Accelerator,
8/27/15 - FDA Approves Amgen's New Cholesterol-Lowering Medication Repatha? (evolocumab)
Amgen today announced that the U.S. Food and Drug Administration has approved a new cholesterol-lowering medication, Repatha? Injection. At Amgen, we are committed to improving the lives of patients and are inspired by the potential for Repatha to aid in the global fight against one of the major risk factors for cardiovascular disease. " "Thro
8/27/15 - FDA approves Amgen's Repatha, 2nd in new class of breakthrough cholesterol drugs
WASHINGTON Amgen Inc. has won approval for the second medicine in a new class of biotech drugs that reduce artery-clogging cholesterol more than older statin drugs that have been used for decades.
8/27/15 - FDA Approves Synjardy Tablets To Treat Adults With Type 2 Diabetes
INDIANAPOLIS- The U.S. Food and Drug Administration has approved Synjardy tablets, from Boehringer Ingelheim Pharmaceuticals Inc and Eli Lilly and Co, for the treatment of adults with type 2 diabetes. Synjardy is the third product containing empagliflozin to be approved by the FDA, following Jardiance and Glyxambi. Synjardy was approved by the Euro
8/27/15 - RetroSense Therapeutics Lead Gene Therapy Candidate Secures FDA Clearance to Proceed to First-in-Human Clinical Trials [Professional Services Close - Up]
RetroSense Therapeutics reported that the Company's Investigational New Drug application for RST-001 received clearance from the United States Food and Drug Administration. This brings us one step closer to realizing our ambition of improving vision in those individuals with currently incurable blindness, "said Sean Ainsworth, CEO of RetroSense...
8/27/15 - RetroSense Therapeutics' Lead Gene Therapy Candidate Gets FDA Clearance to Proceed to First-in-Human Clinical Trials [Manufacturing Close - Up]
RetroSense Therapeutics reported the Company's Investigational New Drug application for RST-001 received clearance from the United States Food and Drug Administration. In 2014, the FDA granted Orphan Drug designation for RST-001 based on its development as a treatment of RP, a rare disease that affects an estimated 100,000 people in the United Stat
8/27/15 - U.S. FDA approves Synjardy (empagliflozin/metformin hydrochloride) tablets for adults with type 2 diabetes
RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 27, 2015/ PRNewswire/ The U.S. Food and Drug Administration has approved Synjardy tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, for the treatment of adults with type 2 diabetes. SYNJARDY is the third product containing empagliflozin to be approved by the FDA, follow
8/27/15 - Veloxis Pharmaceuticals announces financial results for the first six months of 2015 and improves the full year outlook [Global Data Point]
?On 14 August, 2015 Envarsus XR was granted Orphan Drug status by the U.S. Food and Drug Administration for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus.? On 10 July, 2015 Veloxis has received U.S. Food and Drug Administration approval of Envarsus XR for the prophylaxis of rejection in kidney tr
8/27/15 - Xtant Medical Announces FDA Approval of OsteoSelect(R) PLUS [Khaleej Times (United Arab Emirates)]
-Xtant Medical Holdings, Inc., a leader in the development of regenerative medicine products and medical devices, today announced that its wholly owned subsidiary, Bacterin International, Inc., has received FDA 510 clearance of OsteoSelect PLUS Demineralized Bone Matrix Putty. With this notice and clearance from the FDA, Xtant Medical is prepared t
8/26/15 - 'Female Viagra' is approved [Herald, The (Plymouth, England)]
The US Food and Drug Administration approved the drug- known chemically as Flibanserin- which has been produced by Sprout Pharmaceuticals at an FDA advisory committee meeting. Some have criticised it for not working very effectively but Sprout Pharmaceuticals insisted trials had shown an increase "in the number of satisfying sexual events".
8/26/15 - Dr. Shawn Garber of New York Bariatric Group Executes Orbera Gastric Balloon Procedure for Non Surgical Weight Loss [Professional Services Close - Up]
Shawn Garber has successfully implanted the first Orbera intragastric balloon in the Northeast since FDA approval. According to a release, although this procedure has had international success for over 20 years with dramatic weight loss results, the Orbera Gastric Balloon has only just been approved for use in the US by the FDA in the last several
8/26/15 - EIZO Receives FDA 510(k) Clearance for Breast Tomosynthesis for RadiForce GX540 Medical Monitor
Release date- 25082015- Hakusan, Japan- EIZO Corporation announced that it has received FDA 510 clearance for breast tomosynthesis from the U.S. Food and Drug Administration for its 5 megapixel monochrome medical monitor, the RadiForce GX540. With FDA 510 clearance for the RadiForce GX540 in tomosynthesis, mammography, and general radiography, EIZO
8/26/15 - FDA Approves U.S. Product Labeling Update for Sprycel dasatinib to Include Five-Year First-Line and Seven-Year Second-Line Efficacy and Safety Data...
By a News Reporter-Staff News Editor at Biotech Week Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has approved an update to the Sprycel product labeling. "The five- and seven-year data now included in the Sprycel U.S. label offer valuable insight into its long-term e
8/26/15 - FDA Clears RiduZone?: A Patented Supplement to Support a Healthy Appetite, Weight and Cholesterol in Adults
Food and Drug Administration cleared the patented product RiduZone? as a new dietary supplement. The FDA found that RiduZone is a metabolite of oleic acid, which is part of a healthy daily diet. After a comprehensive review of all available literature and data the FDA had no concerns regarding RiduZone's safety.
8/26/15 - US FDA approves 'female Viagra' with strong warning
The US Food and Drug Administration said the pink pill, to be sold under the brand name Addyi and made by privately held Sprout Pharmaceuticals, will only be available through certified and specially trained health care professionals and pharmacies due to its safety issues. Addyi has been nicknamed the' female Viagra' even though it does not work l
8/26/15 - Veloxis Pharmaceuticals announces financial results for the first six months of 2015 and improves the full year outlook
On 14 August, 2015 Envarsus XR was granted Orphan Drug status by the U.S. Food and Drug Administration for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. On 10 July, 2015 Veloxis has received U.S. Food and Drug Administration approval of Envarsus XR for the prophylaxis of rejection in kidney transpla
8/26/15 - Xtant Medical Announces FDA Approval of OsteoSelect(R) PLUS [UMCI News]
-Xtant Medical Holdings, Inc., a leader in the development of regenerative medicine products and medical devices, today announced that its wholly owned subsidiary, Bacterin International, Inc., has received FDA 510 clearance of OsteoSelect PLUS Demineralized Bone Matrix Putty. With this notice and clearance from the FDA, Xtant Medical is prepared t
8/25/15 - EIZO Receives FDA 510(k) Clearance for Breast Tomosynthesis for RadiForce GX540 Medical Monitor
Hakusan, Japan- EIZO Corporation announced that it has received FDA 510 clearance for breast tomosynthesis from the U.S. Food and Drug Administration for its 5 megapixel monochrome medical monitor, the RadiForce GX540. With FDA 510 clearance for the RadiForce GX540 in tomosynthesis, mammography, and general radiography, EIZO continues to provide a
8/25/15 - FDA Approves Dexcom G5 Mobile Continuous Glucose Monitoring System
Dexcom, Inc.,, a leader in continuous glucose monitoring for patients with diabetes, announced today that the U.S. Food and Drug Administration has approved the Dexcom G5 Mobile Continuous Glucose Monitoring System. "Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. These advances a
Articles(s): 1 - 25 of 37     Next >>     Go To Page:


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