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 The leading web portal for pharmacy resources, news, education and careers September 30, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 30, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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9/30/14 - U.S. FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) Extended-Release Injectable Suspension for the Treatment of Schizophrenia
PRINCETON, N.J.& DEERFIELD, Ill. Otsuka Pharmaceutical Development& Commercialization, Inc. and Lundbeck announced today that the U.S. Food and Drug Administration has approved a new formulation of Abilify Maintena for extended-release injectable suspension a pre-filled dual-chamber syringe. Otsuka and Lundbeck continue to be committed to
9/29/14 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Cosmetic Registration Program
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Voluntary Cosmetic Registration Program" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Cole
9/29/14 - Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal...
This notice solicits comments on adverse event reporting by FDA on new animal drugs and product/manufacturing defects collected on paper forms. Submit written comments on the collection of information to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identif
9/29/14 - Allergan Announces FDA Approves Revised Indication for OZURDEX (dexamethasone intravitreal implant) 0.7 mg for the Treatment of Diabetic Macular Edema
Allergan, Inc., announced today that the U.S. Food and Drug Administration has approved OZURDEX 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema. Based on ongoing review of clinical data demonstrating efficacy and safety, the FDA has now approved OZURDEX for use in the general DME patient
9/29/14 - Allergan Says FDA Approves Revised Indication For OZURDEX
WASHINGTON- Allergan, Inc. said the U.S. Food and Drug Administration has approved OZURDEX 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema or DME. OZURDEX was originally approved in June as a treatment for DME in adult patients who have an artificial lens implant or who are scheduled for catara
9/29/14 - Cesca Therapeutics Announces Approval of Its AXP(R) AutoXpress(R) System in Taiwan
Cesca Therapeutics Inc., an autologous cell-based regenerative medicine company, today announced that the Company has received approval from the Taiwan Food and Drug Administration for the sale and distribution of its AXP AutoXpress System and related cell processing bag-set in Taiwan. "We are very pleased to receive approval from the Taiwan FDA
9/29/14 - Cochlear Announces the FDA Approval of True 2.4 GHz Wireless Connectivity With the Cochlear? Nucleus 6 Sound Processor
By a News Reporter-Staff News Editor at Pharma Business Week Cochlear Limited, the global leader in implantable hearing solutions, announced that the US Food and Drug Administration approved the use of 2.4 GHz wireless connectivity with the Cochlear? Nucleus 6 Sound Processor. "The 2.4 GHz wireless protocol is a robust, dependable, third ge
9/29/14 - FDA Approves MOVANTIK? naloxegol Tablets C-II for the Treatment of Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
By a News Reporter-Staff News Editor at Pharma Business Week AstraZeneca announced that the US Food and Drug Administration approved MOVANTIK? Tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation, in adult patients with chronic, non-cancer pain.
9/29/14 - FDA Approves NeuroGenetic Pharmaceuticals Application to Begin Clinical Trials for Its NGP 555 Compound to Treat and Prevent Alzheimer's Disease
The U.S. Food and Drug Administration has approved the Investigational New Drug application from NeuroGenetic Pharmaceuticals, Inc. to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer s disease. William T. Comer, CEO of NGP, a privately held biopharmaceutical company focused on Alzheimer s disease therapeutics, sai
9/29/14 - FDA Approves New Styles Of The MENTOR MemoryShape Silicone Breast Implant
By a News Reporter-Staff News Editor at Clinical Trials Week Mentor Worldwide LLC, the U.S. market leader in breast aesthetics, announced the U.S. Food and Drug Administration has approved four additional styles of the MENTOR MemoryShape Breast Implants, expanding its suite of silicone breast implant products. "This product line demonstrates our
9/29/14 - FDA Clears Next-Generation SURGIMAP 2.0 Software, First Pre-Operative Planning Platform for Personalized Spinal Implants
NEMARIS, Inc. today announced the company has received 510 clearance from the U.S. Food and Drug Administration for the next-generation SURGIMAP 2.0 platform, the preeminent software used to preoperatively plan spine surgery which now offers advanced tools based upon algorithms and the most recent scientific data on the parameters necessary to...
9/29/14 - Intuitive Surgical Receives FDA Clearance for First Single-Site(R) Wristed Needle Driver for da Vinci(R) Si(R) Surgical System
Intuitive Surgical, Inc. today announced that it has received U.S. Food and Drug Administration clearance for the Single-Site Wristed Needle Driver for use in single-incision surgery. "As the first fully articulating robotic single-port instrument available on the market, this is truly a transformative technology for surgeons and patients seekin
9/29/14 - Keck Medical Center of USC surgeon becomes first in world to use FDA cleared advanced robotic technology to remove kidney tumor in outpatient...
Keck Medical Center of USC surgeon becomes first in world to use FDA cleared advanced robotic technology to remove kidney tumor in outpatient procedure. Urologic surgeons at the USC Institute of Urology, part of Keck Medicine of USC, used a Food and Drug Administration- cleared laparoscopic device, the high intensity focused ultrasound surgical abl
9/29/14 - Luminex Receives FDA Clearance To Add New Clinical Targets And Additional Sample Type For Use With xTAG Gastrointestinal Pathogen Panel
Luminex Corporation today announced it has received U.S. FDA clearance to add three new targets to its xTAG Gastrointestinal Pathogen Panel. In addition, FDA has now cleared xTAG GPP for use with specimens in Cary-Blair medium, a common transport medium for collection and preservation of microbiological specimens.
9/29/14 - Studies from Mayo Clinic Yield New Information about Diabetes (Anti-VEGF Therapy for Diabetic Macular Edema)
Only ranibizumab has received U.S. Food and Drug Administration approval for DME, but bevacizumab is commonly used off-label, and an FDA application for aflibercept is pending. For more information on this research see: Anti-VEGF Therapy for Diabetic Macular Edema. Current Diabetes Reports, 2014; 14: 24-33. Current Diabetes Reports can be contacted
9/29/14 - VIVUS And Auxilium Announce FDA Approval Of STENDRA sNDA; STENDRA Now First And Only Oral Erectile Dysfunction Treatment Approved To Be Taken...
By a News Reporter-Staff News Editor at Clinical Trials Week VIVUS, Inc. and Auxilium Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for STENDRA. STENDRA is now the only FDA- approved erectile dysfunction medication indicated to be taken as early as approximately 15 minu
9/28/14 - CivaTech Oncology Receives FDA Approval for CivaSheet? Brachytherapy Device
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA CivaTech Oncology, a medical device company dedicated to developing innovations in radiation therapy, announced it has received FDA clearance on its groundbreaking bioabsorbable, planar radiation device. About CivaTech Oncology CivaTech Oncology Inc. develops innovative low do
9/28/14 - EOS imaging Gets FDA Clearance for sterEOS 3D and sterEOS 1.6 [Professional Services Close - Up]
EOS imaging reported that its next-generation sterEOS 3 D imaging software, sterEOS 1.6, has received 510 clearance from the U.S. Food and Drug Administration. Concurrent with the FDA clearance, the benefits of EOS and its software sterEOS were highlighted at the 49th Annual Meeting of the Scoliosis Research Society in Anchorage, Alaska and during
9/28/14 - EOS Imaging Secures FDA Clearance for New Software Dedicated to Sagittal Balance and Posture Analysis [Professional Services Close - Up]
EOS Imaging said that its next-generation sterEOS 3 D imaging software, sterEOS 1.6, has received 510 clearance from the U.S. Food and Drug Administration. Concurrent with the FDA clearance, the benefits of EOS and its software sterEOS were highlighted at the 49th Annual Meeting of the Scoliosis Research Society in Anchorage, Alaska and during an a
9/28/14 - FDA Approves Stendra sNDA [Manufacturing Close - Up]
Vivus and Auxilium Pharmaceuticals reported that the U.S. Food and Drug Administration has approved a supplemental new drug application for Stendra. According to a media release, Stendra is now the only FDA- approved erectile dysfunction medication indicated to be taken as early as approximately 15 minutes before sexual activity. "Stendra is the f
9/28/14 - Siemens: FDA OKs SOMATOM Scope [Professional Services Close - Up]
Siemens Healthcare recently reported that the Food and Drug Administration has cleared the Somatom Scope, a new 16- slice computed tomography scanner. Designed for private radiology practices, community hospitals, critical access hospitals, specialty practices such as orthopedics and urology, and veterinary medicine, the Somatom Scope is available
9/26/14 - Alimera Sciences Receives FDA Approval For ILUVIEN, The First Long-Term Treatment For Diabetic Macular Edema
Alimera Sciences, Inc., a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the U.S. Food and Drug Administration has approved ILUVIEN for the treatment of diabetic macular edema in patients who have been previously treated with a course o
9/26/14 - Alimera, pSivida say FDA clears eye implant
NEW YORK Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien. Alimera Sciences plans to launch the drug during the first quarter. Alimera Sciences Inc. stock jumped 90 cents, or 18.2 percent, to $5.82 in aftermarket trading.
9/26/14 - Celgene Gets FDA Approval for Oral OTEZLA (apremilast) for Treatment of Patients with Moderate to Severe Plaque Psoriasis [Health & Beauty Close - Up]
Celgene said that the U.S. Food and Drug Administration has approved OTEZLA, the Company's oral, selective inhibitor of phosphodiesterase 4, for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. "OTEZLA offers a valuable treatment option for a spectrum of plaque psoriasis p
9/26/14 - Clear Guide Medical Receives FDA 510(k) Clearance on First Product, the CLEAR GUIDE ONE
Clear Guide Medical announced that its first clinical product, the CLEAR GUIDE ONE, was cleared by the United States' Food and Drug Administration on September 19, 2014. CEO Dorothee Heisenberg stated, "We are extremely pleased that the FDA's 510 process moved along so quickly, and that we are close to receiving our CE and Health Canada certifica
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