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 The leading web portal for pharmacy resources, news, education and careers October 25, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - October 25, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 59     Next >>     Go To Page:

10/25/14 - Eisai Gets FDA Approval of sNDA for Rufinamide [Manufacturing Close - Up]
Eisai recently reported that the U.S. Food and Drug Administration accepted the company's sNDA for rufinamide and granted it priority review designation as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients from 1 to 4 years of age. Priority Review designation was assigned to this sNDA because FDA...
10/25/14 - FDA OKs Lutonix 035 Drug Coated Balloon [Professional Services Close - Up]
C. R. Bard recently reported that the U.S. Food and Drug Administration has granted approval of the Lutonix 035 Drug Coated Balloon Catheter for percutaneous transluminal angioplasty, after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal art
10/24/14 - AbbVie's HUMIRA adalimumab Receives U.S. FDA Approval for Extension of Polyarticular Juvenile Idiopathic Arthritis Indication to Patients Ages 2 and...
AbbVie's HUMIRA adalimumab Receives U.S. By a News Reporter-Staff News Editor at Health& Medicine Week AbbVie announced that the U.S. Food and Drug Administration has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients ages 2 an
10/24/14 - Covidien Announces U.S. Food and Drug Administration 510k Clearance for Nellcor? Portable SpO2 Patient Monitoring System
By a News Reporter-Staff News Editor at Health& Medicine Week Covidien plc announced U.S. Food and Drug Administration 510 clearance for the Nellcor? Portable SpO2 Patient Monitoring System. Part of a comprehensive Covidien respiratory function monitoring portfolio, this convenient, handheld patient monitor is simple to use and ideal for fast,
10/24/14 - FDA Approves New Treatment for Rare Form of Hemophilia
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 yesterday approved Obizur for the treatment of bleeding episodes in adults with acquired hemophilia A. "The approval of this product provides an important therapeutic option for use in the care of
10/24/14 - Pulsaderm Releases FDA-Cleared Class II Medical Device LED Red [Manufacturing Close - Up]
Pulsaderm recently launched the Pulsaderm Buddy sonic face brush and the FDA- cleared Pulsaderm LED Blue light therapy device, is bolstering its skincare line with the announcement of the FDA- Cleared Class II Medical Device, Pulsaderm LED Red. "Coming off the heels of the successful debut of Pulsaderm's LED Blue, we're thrilled to complement our
10/24/14 - Zyno Medical, LLC Receives FDA 510(k) Clearance for Ambulatory Infusion Pump
NATICK, Mass., Oct. 24, 2014/ PRNewswire-iReach/ Zyno Medical, LLC today announced that it has received 510 clearance from the U.S. Food and Drug Administration in addition to European CE Mark for their ambulatory infusion system, and will market it under the trade name "Nimbus" (TM). Zyno Medical, LLC plans to launch Nimbus? with deployments t
10/23/14 - Arbor Pharmaceuticals Announces FDA Approval of Sotylize?
Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved its New Drug Application for Sotylize oral solution. It is such a common practice that the FDA changed the tablet labeling to include instructions for pharmacists on how to compound a simple syrup based sotalol suspension. Ed Schutter, President& CEO of
10/23/14 - Covidien: FDA Clears Nellcor Portable SpO2 Patient Monitoring System [Manufacturing Close - Up]
Covidien reported that U.S. Food and Drug Administration recently issued 510 clearance for the Nellcor Portable SpO2 Patient Monitoring System. The company said that this handheld patient monitor, part of a Covidien respiratory function monitoring portfolio, is simple to use and ideal for motion-tolerant monitoring of pulse rate and blood oxygenati
10/23/14 - Cytori Therapeutics Receives FDA Approval to Resume ATHENA Trial Enrollment [Global Data Point]
Based on consultation with the FDA, Cytori initiated a thorough safety review consisting of evaluating each adverse event in all of its previous and ongoing cardiovascular trials and conducted additional testing of its product and cellular output. The FDA response to Cytori's submission was received on October 22, 2014.&# x0D;. Marc Hedrick, Presid
10/23/14 - Dexcom Secures FDA Approval for Dexcom SHARE [Manufacturing 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
10/23/14 - Fitch: FDA Drug Approvals Up for Breakthrough Entities, Biologics [Manufacturing 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
10/23/14 - Harvoni Approved For The Treatment Of Chronic Hepatitis C; TapImmune Provides Update on PolyStart? Vaccine Platform
FDA announced October 10, 2014 that Gilead Sciences Harvoni product was approved for the treatment of chronic hepatitis C, genotype 1 infection in adults. Sofosbuvir was approved by the FDA under the trade name Sovaldi in December 2013. Harvoni is a product of Gilead Sciences, based in Foster City, California.======================== TapIm
10/23/14 - Kubtec Announces FDA Approval of World's First Breast Specimen Tomosynthesis System During Breast Cancer Awareness Month
In providing the most comprehensive analysis of excised breast tissue in a specimen radiography system, MOZART can help reduce re-excision and patient call back rates. "MOZART with TomoSpec allows 3 D margin assessment in one step, without turning and repositioning the specimen container," said Vikram Butani, President of Kubtec. MOZART with TomoS
10/23/14 - Orexigen Therapeutics Analyst Coverage Initiated with Price Target by BrokerBank Securities, Inc.
In the United States alone, more than one-third of all adults are considered to be obese, costing the US healthcare system an estimated $150 billion each year. The company recently received FDA approval for its leading drug candidate Contrave in September 2014. Orexigen has a collaboration agreement with Japan's Takeda Pharmaceuticals to develop an
10/23/14 - Reflexonic LLC Cleared for OTC Sales of Viberect ED Treatment in the US
Reflexonic LLC, developer of the Viberect non-pharmaceutical device for treating erectile dysfunction in men, has achieved Food and Drug Administration clearance to market the product over the counter in the US. Viberect is already registered for sale so far in the US, European Union, Australia, Canada and India. Now, with support from Austin, Tex.
10/23/14 - WaisMed Ltd. Receives FDA Approval and a CE Mark for the NIO, a New Intraosseous Medical Device
WaisMed Ltd., one of the prime portfolio companies of the PerSys Medical Group, has received FDA approval and a CE mark for the NIO, a new intraosseous medical device for adults. Roee Madai, the CEO of WaisMed Ltd. says, "We are extremely proud and happy to bring this product to market; this is yet another achievement in the long tradition of Persy
10/22/14 - AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode
AVACEN Medical announced today that its AVACEN 100 Class II medical device received 510 OTC clearance by the U.S. Food and Drug Administration. This clearance allows the AVACEN 100 to be marketed over the Internet for: the temporary relief of joint pain associated with arthritis; muscle spasms; and minor strains and sprains. In' Game Mode,' the t
10/22/14 - CAGW Releases Poll Results Regarding Use of Biosimilar Drugs
A legal framework to approve biosimilars was established in Europe in 2003, and they have been used safely since the first medication was approved in 2006. However, four years after the passage of PPACA, not a single biosimilar has been approved by the FDA. CAGW's poll shows that 78 percent of voters agree that healthcare costs are out of control a
10/22/14 - Centric Medical? Announces FDA Clearance of TARSA-LINK? Internal Fixation System for Foot and Ankle
Centric Medical, a new division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today 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 a
10/22/14 - Cytori Therapeutics Receives FDA Approval to Resume ATHENA Trial Enrollment
Cytori Therapeutics, Inc. has received notification from the FDA that Cytori has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials. The FDA has agreed that the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude...
10/22/14 - FDA approves Auxilium's Xiaflex to treat Dupuytren's Contracture [EMBIN (Emerging Markets Business Information News]
The US Food and Drug Administration has approved a supplemental Biologics Application for Auxilium Pharmaceuticals' Xiaflex to treat up to two Dupuytren's contracture joints in the same hand during a single treatment visit. Xiaflex is approved in the US, EU, Canada and Australia to treat adult DC patients with a palpable cord. Auxilium Pharmaceutic
10/22/14 - FDA approves more manufacturing facilities for Halozyme's Hylenex recombinant production [EMBIN (Emerging Markets Business Information News]
Halozyme Therapeutics has received approval from the US Food and Drug Administration for new contract manufacturing facilities used in the production of Hylenex recombinant. The approval allows the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and t
10/22/14 - FDA Grants Clearance to Proceed with Clinical Study - New Drug Candidate from Vivolux Could Overcome Drug Resistance
By a News Reporter-Staff News Editor at Biotech Week Vivolux, a pharmaceutical company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX1570 to clinical phase I/II for treatment against relapsed and/or refractory multiple myeloma. The clinical study will be conducted in collaboration with the Memori
10/22/14 - Ferring Pharmaceuticals Inc. Receives FDA Approval For New Cranberry Flavor Of PREPOPIK Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric...
Ferring Pharmaceuticals Inc. Receives FDA Approval For New Cranberry Flavor Of PREPOPIK Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid. To offer an alternative choice in bowel preparation, Ferring Pharmaceuticals Inc. will introduce a new cranberry flavor option of PREPOPIK in January 2015. Gastroenterology business unit at Ferri
Articles(s): 1 - 25 of 59     Next >>     Go To Page:


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