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 The leading web portal for pharmacy resources, news, education and careers October 31, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - October 31, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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10/31/14 - United States : First vaccine approved by FDA to prevent serogroup B Meningococcal disease [TendersInfo (India)]
The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. According to the Centers for Disease Control and Prevention, about 500 total cases of mening
10/30/14 - Astrazeneca Receives U.S FDA Approval For Type-2 Diabetes Medecine XIGDUO XR
LONDON- Astrazeneca plc Thursday said U.S. Food and Drug Administration approved its once-daily XIGDUO XR for type-2 diabetes in adults. XIGDUO XR, an extended release of XIGDUO, has already been approved in Australia for type-2 diabetes and XIGDUO is approved by European Union. XIGDUO XR combines dapagliflozin and metformin hydrochloride...
10/30/14 - EOS imaging Garners Marketing Approval in South Korea [Health & Beauty Close - Up]
EOS imaging has received approval from the Korean Food and Drug Administration to market the EOS system in South Korea. EOS imaging said the KFDA approval will enable the Company to continue expanding its presence in the Asia Pacific medical imaging market, which is predicted to see the highest growth globally during the next 5 years1. We are proud
10/30/14 - FDA Approves Protein Sciences Flu Vaccine For Older Americans [The Hartford Courant]
Oct. 30 The Food and Drug Administration has extended its approval the flu vaccine made by Meriden's Protein Sciences to adults 50 years old and above. The vaccine, Flublok, acquired its first stamp of approval from federal regulators in January 2013, but only for those aged 18 to 49. Making the drug available to older people is important for pub
10/30/14 - FDA Approves TactiCath Quartz [Health & Beauty Close - Up]
St. Jude Medical has received U.S. Food and Drug Administration approval of its TactiCath Quartz irrigated ablation catheter, technology that gives physicians a real-time, objective measure of the force that the catheter applies to a patient's heart wall during an ablation procedure. Vivek Reddy, director of electrophysiology at Mount Sinai Hospita
10/30/14 - InVivo Therapeutics Receives FDA Approval to Broaden Inclusion Criteria and Add 14 Additional Sites (20 Total) for Ongoing Pilot Trial [Global Data Point]
With this approval, the upper end of the age range has been increased from 55 to 65, the spinal cord injury level has been expanded from T3-T11 to T3-T12/L1, the enrollment window has been extended from 10 to 21 days post injury, and the Body Mass Index upper limit has been increased from 35 to 39.&# x0D;. Mark Perrin, InVivo's CEO, said, "We have
10/30/14 - Mylan Launches Generic Viramune XR
Mylan Inc. today announced the U.S. launch of its Nevirapine Extended-release tablets, 400 mg, which is the generic version of Boehringer Ingelheim's Viramune XR . Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated for combination antiretroviral
10/30/14 - Pfizer Receives FDA Accelerated Approval for TRUMENBA (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Adolescents and Young Adults
Release date- 29102014- Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted accelerated approval of TRUMENBA for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. As part of the accelerated approval process, Pfizer will complete its
10/30/14 - Sunrise Holdings' Unit in Licensing Agreement for BreastCare DTS(TM) With Life Medical Technologies
Sunrise Holdings, Limited, a Nevada company in the medical device business, has entered into a licensing agreement, via its subsidiary Efil Sub of ECG Inc., with Life Medical Technologies, Inc. with respect to Life Medical's "BreastCare DTS? device" and certain other derivative technologies. The License Agreement grants Efil the exclusive right t
10/30/14 - Tumor segmentation software receives 510k clearance from FDA
By a News Reporter-Staff News Editor at Computer Weekly News NEW YORK, NY-Columbia University's imaging software that facilitates 3- D lung tumor segmentation, licensed to Varian Medical Systems, has been incorporated into the Smart Segmentation module of Varian's Eclipse? treatment planning system and has received FDA 510 k clearance.
10/30/14 - TWi Pharmaceuticals Receives US FDA Approval on Generic Donepezil Hydrochloride Tablets USP, 23 mg, its fifth ANDA from US FDA
TWi Pharmaceuticals, Inc. today announced that it has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.' s Aricept 23 mg. TWi Pharmaceuticals is preparing to launch the product in the US via its
10/30/14 - U.S. approves first vaccine against dangerous meningitis strain
The vaccine Trumenba, to be manufactured by Pfizer Inc., is approved for people between the ages of 10 and 25 years of age and protects against Neisseria meningitidis serogroup B, the FDA said in a statement Wednesday. Karen Midthun, director of the Center for Biologics Evaluation and Research at the FDA. Although this illness can affect any popula
10/30/14 - U.S. FDA Approves Once-Daily XIGDUO? XR Tablets for Adults with Type 2 Diabetes
AstraZeneca today announced that the U.S. Food and Drug Administration has approved once-daily XIGDUO? XR for the treatment of adults with type 2 diabetes. XIGDUO XR is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. The addition of XIGDUO XR to our
10/30/14 - U.S. Food and Drug Administration Approves Gilead's Harvoni Ledipasvir/Sofosbuvir, the First Once-Daily Single Tablet Regimen for the Treatment of...
By a News Reporter-Staff News Editor at Politics& Government Week Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has approved Harvoni , the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. The FDA granted Harvoni a Priority Review and Breakthrough Therapy
10/30/14 - US FDA Approves AstraZeneca Type 2 Diabetes Treatment Xigduo XR
LONDON- AstraZeneca PLC Thursday said the US Food and Drug Administration has approved its once-daily XIGDUO XR drug for the treatment of adults with type 2 diabetes. XIGDUO XR is already approved in Australia for the treatment of adults with type 2 diabetes, along with diet and exercise. XIGDUO, meanwhile, is approved in the European Union.
10/30/14 - US FDA APPROVES ONCE-DAILY XIGDUO? XR TABLETS
US FDA APPROVES ONCE-DAILY XIGDUO? XR TABLETS FOR ADULTS WITH TYPE 2 DIABETES First US approval for once-daily tablet combining SGLT2 inhibitor and metformin HCl extended-release AstraZeneca today announced that the US Food and Drug Administration has approved once-daily XIGDUO? XR (dapagliflozin and metformin hydrochloride extended-release) fo
10/29/14 - BRIEF: BSP receives FDA approval for ECG test [Globes, Tel Aviv, Israel]
Oct. 29 Despite its long years on the stock exchange with little or no sales, BSP Biological Signal Processing Ltd. is not giving up. The company today reported that it had obtained FDA approval to market its device for more accurate diagnosis of heart attacks using an ECG at rest. The company's revenue in the first half of the year totaled a t
10/29/14 - Dexcom Gets FDA Approval for Dexcom SHARE [Professional Services Close - Up]
Dexcom has received U.S. Food and Drug Administration approval for its CGM remote mobile communications device: Dexcom SHARE. According to a release from the company, Dexcom SHARE, an accessory to the Dexcom G4 PLATINUM Continuous Glucose Monitoring System, uses a secure wireless connection to transmit the glucose levels of a person with diabetes t
10/29/14 - FDA Approves Baxter International's Obizur for Hemophilia A [Health & Beauty Close - Up]
Baxter International reported that the United States Food and Drug Administration has approved Obizur for the treatment of bleeding episodes in adults with acquired hemophilia A, a very rare and potentially life-threatening acute bleeding disorder. According to a release from the company, Obizur was granted orphan-drug status by the FDA and its rev
10/29/14 - FDA Approves Esbriet pirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis IPF in the United States
By a News Reporter-Staff News Editor at Biotech Week Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Esbriet as a treatment for idiopathic pulmonary fibrosis in the United States. "With today's approval of Esbriet in the United States, people with IPF finally have an FDA- approved medi
10/29/14 - FDA approves vaccine to block meningitis strain
The Food and Drug Administration said Wednesday it cleared Pfizer's Trumenba to prevent a subtype of Meningococcal disease in people ages 10 to 25. When the bacteria infect the bloodstream they cause sepsis. Last year the University of California, Santa Barbara and Princeton University both experienced separate, unrelated outbreaks of meningococcal
10/29/14 - First Vaccine Approved by FDA to Prevent Serogroup B Meningococcal Disease
The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. According to the Centers for Disease Control and Prevention, about 500 total cases of mening
10/29/14 - Fitch: FDA Drug Approvals Up for Breakthrough Entities, Biologics [Professional Services Close - Up]
The following is from Fitch Ratings on October 20:. The number of NME approvals by the FDA during the first nine months in 2014 was up from the first nine months of 2013. The FDA cleared 33 novel medicines for U.S. marketing during the first five months of 2014, compared with 17 in 2013. The FDA has approved seven breakthrough therapies year to dat
10/29/14 - Flublok Influenza Vaccine Now Approved for Adults Ages 18 and Older
FDA has approved Flublok influenza vaccine for all adults aged 18 years and older, granting approval for use in people 50 and older under the accelerated approval of biological products regulations, 21 CFR 601.40-46. Flublok is the only licensed flu vaccine that is made using modern recombinant technology and the only flu vaccine that is 100% egg-f
10/29/14 - InspireMD Investigational Device Exemption (IDE) amendment approved by the FDA
InspireMD, Inc., a leader in Embolic Protection Systems, today announced that the FDA has approved the Company's submitted IDE amendment for certain manufacturing process changes to the MGuard Prime EPS that were proposed in response to the Company's April 30, 2014 Voluntary Field Action. InspireMD said while patient enrollment in the US MASTER I
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