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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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10/29/14 - 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
10/29/14 - InVivo Therapeutics Receives FDA Approval to Broaden Inclusion Criteria and Add 14 Additional Sites (20 Total) for Ongoing Pilot Trial
InVivo Therapeutics Holdings Corp. today announced that the US Food and Drug Administration has approved various changes to the protocol for the company s ongoing IDE pilot trial for acute spinal cord injury, including expanding the number of allowable clinical sites to 20 and broadening the eligibility criteria. InVivo Therapeutics Holdings Cor
10/29/14 - Lannett Receives FDA Approval for Letrozole Tablets USP 2.5 mg
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Letrozole Tablets USP, 2.5 mg, the therapeutic equivalent to the reference listed drug, Femara Tablets, 2.5 mg, of Novartis Pharmaceuticals Corporation. Letrozole Tablets USP, 2.5 mg, repre
10/29/14 - Pfizer Gets FDA Accelerated Approval For Meningococcal Group B Vaccine TRUMENBA
NEW YORK CITY- Pfizer Inc. said Wednesday 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 ongoing st
10/29/14 - Pfizer Receives FDA Accelerated Approval for TRUMENBA (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Adolescents and Young Adults
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 ongoing studies to co
10/29/14 - United States : ZYNO MEDICAL gets FDA clearance for merchandising Nimbus ambulatory infusion pump [TendersInfo (India)]
Zyno Medical declared that it has obtained the FDA clearance to bring to market its Nimbus ambulatory infusion pump. Both continuous rate and patient-controlled analgesia infusions is being provided by this device and created for intuitive programming by clinicians and easy use by patients. The product features: Fluid delivery accuracy of+/- 5%; Ea
10/28/14 - BRIEF: FDA gives Phase III nod for Intec Parkinson's treatment [Globes, Tel Aviv, Israel]
Oct. 28 Intec Pharma Ltd. reported today that it had received US Food and Drug Administration approval for carrying out a Phase III trial of its Accordion Pill Levodopa for the treatment of Parkinson's Disease. Intec says that it will conduct discussions with the FDA on the protocol for the trial. Intec chairman Zvi Joseph said, "We are very prou
10/28/14 - Dallen Medical Receives FDA Clearance for Tensyn? Band for AC/CC Joint Stabilization
Dallen Medical Inc., an innovator in bone fixation and repair, today announced 510 clearance from the U.S. Food and Drug Administration for its Tensyn? Band for acromioclavicular joint and coracoacromial ligament repair in shoulder separation. This approval marks our eighth FDA clearance as a company and the third within the Tensyn Band family
10/28/14 - ProMetic's Plasminogen IND and Clinical Program Cleared by FDA
ProMetic Life Sciences Inc. announced today that the US Food and Drug Administration has completed its review and has cleared the Investigational New Drug application for ProMetic's IV plasminogen for the treatment of hypoplasminogenemia, or type I plasminogen deficiency. The FDA has also accepted that ProMetic's proposed Phase II/ III clinical pro
10/28/14 - St. Jude wins FDA approval for ablation device [Star Tribune (Minneapolis)]
Oct. 28 St. Jude Medical has received approval to sell a device that should let doctors more accurately perform ablation procedures that aim to correct an irregular heartbeat by destroying tiny bits of tissue. Jude, based in Little Canada, announced Monday that it received approval from the Food and Drug Administration to sell its TactiCath Quart
10/28/14 - United States : FDA Approves Baxter's OBIZUR Antihemophilic Factor (Recombinant), Porcine Sequence , for Acquired Hemophilia A [TendersInfo (India)]
Baxter International Inc. today announced that the United States Food and Drug Administration has approved OBIZUR Antihemophilic Factor, Porcine Sequence for the treatment of bleeding episodes in adults with acquired hemophilia A, a very rare and potentially life-threatening acute bleeding disorder. OBIZUR was granted orphan-drug status by the FDA.
10/27/14 - AnthroTronix Receives FDA Clearance for Brain Health Assessment Tool
By a News Reporter-Staff News Editor at Pharma Business Week AnthroTronix, a research and development company that designs health technology, announced it has received U.S. Food and Drug Administration clearance for its computerized cognitive test battery known as DANA?. "We are pleased that DANA? has sought and received FDA clearance, leadi
10/27/14 - Bracco Diagnostics Inc. Receives U.S. FDA Approval for New Ultrasound Contrast Agent
By a News Reporter-Staff News Editor at Clinical Trials Week Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A.- a global leading company in the diagnostic imaging business- announced that the U.S. Food and Drug Administration has approved its new ultrasound contrast agent Lumason? for injectable suspension, indicated for use
10/27/14 - FDA Approves AKYNZEO netupitant/palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting CINV
By a News Reporter-Staff News Editor at Clinical Trials Week Helsinn Group and Eisai Inc. announced that the Food and Drug Administration approved AKYNZEO for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
10/27/14 - FDA Approves Boehringer Ingelheim's OFEV nintedanib as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
By a News Reporter-Staff News Editor at Clinical Trials Week Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration approved OFEV capsules for oral use for the treatment of idiopathic pulmonary fibrosis. Granted Breakthrough Therapy designation during its review by the FDA, OFEV, capsules for oral use,
10/27/14 - FDA Approves Breakthrough in Pediatric Brain Cancer - First in 30 Years
Amber Larkin, the founder of Noah's Light Foundation, proves that one mom's determination can make a difference. "Noah was diagnosed just before Halloween trick-or-treating, and it's only fitting that we've received FDA approval to begin testing this month," says Larkin. In 2011, Larkin met Laurence Cooper, M.D., Ph.D., professor of Pediatrics wit
10/27/14 - FDA Clears Centric Medical's Tarsa-Link System [Health & Beauty Close - Up]
Centric Medical reported that the U.S. Food and Drug Administration has given 510 marketing clearance to its Tarsa- Link system, for internal bone fixation of fractures, fusions, and osteotomies in the foot and ankle. According to a release from the company, Tarsa-Link represents a new osteotomy wedge fusion system and joins Centric Medical's suite
10/27/14 - Gynesonics Gets FDA Approval for a Pivotal IDE Clinical Trial for Vizablate System [Health & Beauty Close - Up]
Gynesonics reported it has received approval from the U.S. Food and Drug Administration of an investigational device exemption for the pivotal trial, Sonography Guided Transcervical Ablation of Uterine Fibroids, of its newly-designed VizAblate System. "We are pleased to have FDA approval to begin this pivotal trial thus validating the pre-clinical
10/27/14 - Insys Receives DEA Approval to Produce Pharmaceutical Cannabidiol; Updates on Status of Its Cannabinoid Program [Manufacturing Close - Up]
Insys Therapeutics, Inc. reported that its Food and Drug Administration inspected and Drug Enforcement Agency approved facility in Round Rock, Texas, has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol. Insys believes these quantities are sufficient to pursue its CBD development program as currently planned.
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