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

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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8/20/14 - Biogen Idec: FDA Approves Plegridy for the Treatment of Multiple Sclerosis [Health & Beauty Close - Up]
Biogen Idec on August 15 reported that the U.S. Food and Drug Administration has approved Plegridy, a treatment for people with relapsing forms of multiple sclerosis. "Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon trea
8/20/14 - FDA Approves Gmate Smart Meter and App [Health & Beauty Close - Up]
Philosys reported that it has received U.S. Food and Drug Administration 510 K approval for the Gmate Smart Blood Glucose Monitoring System. Philosys said in a release that the Gmate Smart meter is the size of a quarter and connects to the headphone jack on the iPhone, iPod touch or iPad, while using the free Gmate Smart app to deliver blood glucos
8/19/14 - Eli Lilly: FDA Grants Tentative Approval For Insulin Drug Basaglar
INDIANAPOLIS- Eli Lilly and Co said Monday the U.S. Food and Drug Administration granted tentative approval for Basaglar, which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Basaglar is Eli Lilly and Boehringer Ingelheim's basal
8/19/14 - FDA Approves Genzyme's Cerdelga? (eliglustat) Capsules
Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration has approved Cerdelga? capsules, the only first-line oral therapy for certain adult Gaucher disease type 1 patients. Cerdelga is an important new option for people living with Gaucher disease type 1, said Rhonda Buyers, CEO of the National Gaucher Foundati
8/19/14 - FDA approves new drug for rare genetic disease
Cerdelga is from Genzyme, the specialty drugmaker that introduced the first drug for Gaucher's disease 20 years ago. The oral treatment could serve as an alternative to Genzyme's best-selling drug Cerezyme, which is given intravenously. Genzyme says it will soon release pricing for its new drug.
8/19/14 - FDA Approves New Drug to Treat a form of Gaucher Disease
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today approved Cerdelga for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder. "Today's approval offers another important treatment option
8/19/14 - FDA Approves Use of AFLURIA Influenza Vaccine with PharmaJet's Needle-Free Injector
KING OF PRUSSIA, Pa.& GOLDEN, Colo. PharmaJet Inc., the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL Inc., the maker of AFLURIA today announced the U.S. Food and Drug Administration has approved the PharmaJet Stratis 0.5 mL Needle-Free Jet Injector for delivery of AFLURI
8/19/14 - FDA Grants Tentative Approval For Lilly And Boehringer Ingelheim's Basaglar
INDIANAPOLIS- Eli Lilly and Co. and Boehringer Ingelheim said Monday that the U.S. Food and Drug Administration has granted tentative approval for Basaglar, or insulin glargine injection, which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type
8/19/14 - Genzyme Receives FDA Approval For Cerdelga Capsules
PARIS- Genzyme, a Sanofi company announced that it has received approval from the U.S. Food and Drug Administration or FDA for its Cerdelga capsules, the only first-line oral therapy for certain adult Gaucher disease type 1 patients. Genzyme has been researching an oral therapy for Gaucher disease for fifteen years, from early chemistry and preclin
8/19/14 - New hybrid hearing device helps those who find hearing aids to be ineffective [The Florida Times-Union, Jacksonville :: ]
A new device, a Cochlear Nucleus Hybrid Implant System, has been approved by the FDA for use in people who have some hearing but have found hearing aids ineffective. J. Douglas Green Jr., a neurotologist and founder of the Jacksonville Hearing& Balance Institute/ The Hearing Center, calls the device "an extraordinary melding of technologies." Green
8/19/14 - Type 1 Diabetes Treatment Funded by California Stem Cell Agency Cleared To Begin Clinical Trial
The Food and Drug Administration gave ViaCyte the go-ahead after reviewing their application for an Investigational New Drug application. "Working in collaboration with CIRM for the past 6 years, ViaCyte has developed a particularly novel approach to overcome the challenges of treating type 1 diabetes. "The ViaCyte team is very pleased to have re
8/18/14 - ElMindA Announces FDA Clearance of BNA? Analysis System
By a News Reporter-Staff News Editor at Pharma Business Week ElMindA Ltd. announced that the United States Food and Drug Administration has cleared the company's BNA? Analysis System for the assessment of brain function. "Greater understanding of how our brain processes information, how it gets its job done, ultimately holds the potential to i
8/18/14 - FDA approves Jardiance empagliflozin tablets for adults with type 2 diabetes
By a News Reporter-Staff News Editor at Clinical Trials Week Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced the U.S. Food and Drug Administration approved Jardiance tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes. JARDIANCE is not fo
8/18/14 - FDA approves Roche's Avastin plus chemotherapy for treatment of advanced cervical cancer
Release date- 15082014- Roche today announced that the U.S. Food and Drug Administration approved Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.1. With this approval in advanced cervical cancer, Avastin is approved in the U
8/18/14 - FDA Approves the SynCardia Total Artificial Heart With SynHall Valves
By a News Reporter-Staff News Editor at Pharma Business Week SynCardia Systems, Inc. received approval July 2, 2014 from the United States Federal Drug Administration for the SynCardia temporary Total Artificial Heart with SynHall? valves, giving the company control over the last key component to manufacture the Total Artificial Heart.
8/18/14 - FDA Clears Mayo Clinic for Manufacture of NurOwn and Participation in BrainStorm's Phase 2 ALS Trial
NEW YORK, NY and PETACH TIKVAH, Israel/ ACCESSWIRE/ August 18, 2014/ BrainStorm Cell Therapeutics, a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the U.S. Food and Drug Administration has cleared the Mayo Clinic Human Cellular Therapy Laboratory in Rochester, Minn. for production of NurOwn?
8/18/14 - FDA Clears Mayo Clinic for Manufacture of NurOwn and Participation in BrainStorms Phase 2 ALS Trial
NEW YORK, NY and PETACH TIKVAH, Israel, via ETELIGIS INC., 08/18/2014 B rainStorm Cell Therapeutics, a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the U. S. Food and Drug Administration has cleared the Mayo Clinic Human Cellular Therapy Laboratory in Rochester, Minn. for production of Nur
8/18/14 - FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar? (insulin glargine injection)
Basaglar is Eli Lilly and Company and Boehringer Ingelheim's basal insulin, which is intended to provide long-lasting blood sugar control in between meals and during the night. 1. With a tentative approval, the FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30
8/18/14 - Infected Doctor Cleared, Discharged to Go Home
This came as Nigeria averted a potential showdown, especially with the United States of America, as the Federal Government said it would no longer administer the Nano- silver drugs on Ebola patients according to a statement by the Special Assistant to the Minister of Health on Media and Communication, Dan Nwomeh. The United States Food and Drug Adm
8/18/14 - Lannett Receives FDA Approval for Oxycodone Hydrochloride Capsules 5 mg
By a News Reporter-Staff News Editor at Pharma Business Week Lannett Company, Inc. announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Oxycodone Hydrochloride Capsules, 5 mg, the therapeutic equivalent to the reference listed drug, Oxycodone Hydrochloride Capsules, 5 mg, o
8/18/14 - United States : B BRAUN's Nutrilipid 20% gets approval from US FDA [TendersInfo (India)]
The US Food and Drug Administration has given go ahead to B. Braun Medical's Nutrilipid 20 per cent. Rick Williamson, vice president of pharmaceutical marketing at B.Braun, commented We are very pleased that the FDA has granted approval for Nutrilipid 20 per cent. B. Braun Medical Inc. is a leader in infusion therapy and pain management.
8/18/14 - United States : FDA approves new at-home stool test to screen for colon cancer [TendersInfo (India)]
The US Food and Drug Administration has sanctioned a new at-home stool test to screen for colon cancer that can better detect cancer than presently-used tests that check for hidden blood in the stool. The FDA says Cologuard succeeded in detecting 92 percent of colorectal cancers and 42 percent of advanced adenomas, as against FIT's 74 percent of ca
8/18/14 - Vital Images, Inc. Receives 510(k) Clearance for Image Denoising Software
Vital Images, Inc., a Toshiba Medical Systems Group Company, received 510 clearance from the U.S. Food and Drug Administration for Image Denoising software, a post-processing filter designed to be used in conjunction with original image data used with its Vitrea software. Vital's denoising filter, Structure Preserving Diffusion, focuses on inc
8/17/14 - FDA Approves Boehringer Ingelheim's Striverdi Respimat olodaterol Inhalation Spray for Maintenance Treatment of COPD
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Boehringer Ingelheim announced that the U.S. Food and Drug Administration has approved Striverdi Respimat Inhalation Spray 5 mcg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, inclu
8/16/14 - Biogen Idec: FDA Approves Plegridy To Treat Multiple Sclerosis
WESTON- Biogen Idec said Friday the U.S. Food and Drug Administration approved Plegridy as a new treatment for people with relapsing forms of multiple sclerosis. The FDA approval is based on a study whereby Plegridy showed a reduction in relapses, disability progression and the number of MS lesions when compared with placebo. Biogen Idec stock clos
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