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 The leading web portal for pharmacy resources, news, education and careers August 29, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - August 29, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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8/25/15 - Xtant Medical Announces FDA Approval of OsteoSelect(R) PLUS
Xtant Medical Holdings, Inc., a leader in the development of regenerative medicine products and medical devices, today announced that its wholly owned subsidiary, Bacterin International, Inc., has received FDA 510 clearance of OsteoSelect PLUS Demineralized Bone Matrix Putty. With this notice and clearance from the FDA, Xtant Medical is prepared
8/24/15 - BioDelivery Sciences Announces FDA Approval of New Formulation of ONSOLIS fentanyl buccal soluble film CII
By a News Reporter-Staff News Editor at Biotech Business Week BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application for a new formulation of ONSOLIS CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. Early this ye
8/24/15 - Boston Scientific Obtains FDA Approval of Innova Vascular Self- Expanding Stent System [Professional Services Close - Up]
Boston Scientific has received Food and Drug Administration approval for the Innova Vascular Self-Expanding Stent System, an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery. According to a release from Boston Scientific, this can cause peripheral artery disease, a...
8/24/15 - Boston Scientific Receives FDA Approval of Innova Vascular Self- Expanding Stent System [Manufacturing Close - Up]
Boston Scientific Corp. has received Food and Drug Administration approval for the Innova Vascular Self-Expanding Stent System, an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery. According to a release from the company, this can cause peripheral artery disease, a...
8/24/15 - FDA Approves Taro's Keveyis? dichlorphenamide 50 mg Tablets for Primary Hyperkalemic and Hypokalemic Periodic Paralysis
By a News Reporter-Staff News Editor at Pharma Business Week Taro Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has approved Keveyis? 50 mg Tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or par
8/24/15 - FDA Approves U.S. Product Labeling Update for Sprycel (dasatinib) [Professional Services Close - Up]
Bristol-Myers Squibb Company and Otsuka America Pharmaceutical reported that the U.S. Food and Drug Administration has approved an update to the Sprycel product labeling. "The five- and seven-year data now included in the Sprycel U.S. label offer valuable insight into its long-term efficacy and safety profile in both first- and second-line patient
8/24/15 - FDA expands use of Novartis drug Promacta to include treatment of children ages 1 and older with chronic immune thrombocytopenia
Novartis announced today that the US Food and Drug Administration has approved an expanded use for Promacta to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was approved by the FDA as a tablet formulation in June 2
8/24/15 - Non-synthetic Color Spectrum Expands as FDA Approves Colorcon's Spirulina Extract Petition [Global Data Point]
This approval will allow the use of Spirulina Extract in coating formulations applied to dietary supplements, drug tablets and capsules marketed in the United States.&# x0D;. The FDA, after their review of Colorcon's updated safety assessment and additional product stability testing performed by Colorcon, agreed to expand the range of product categ
8/24/15 - NOWDiagnostics Inc. Receives FDA Clearance for ADEXUSDx hCG Test
By a News Reporter-Staff News Editor at OBGYN& Reproduction Week NOWDiagnostics' ADEXUSDx? hCG point-of-care test, which uses only a single drop of capillary or whole blood to quickly and accurately diagnose pregnancy earlier than urine-based tests, has now been CLIA registered and classified by the U.S. Food and Drug Administration. The new hC
8/24/15 - Presbia Surpasses Treatment of 300 Subjects as Part of the US FDA Pivotal Study Enrollment
By a News Reporter-Staff News Editor at Pharma Business Week Presbia PLC, an ophthalmic device company and leader in near vision restoration announced that it is approaching completion of patient enrollment of its U.S. Food and Drug Administration pivotal study for the Presbia Flexivue MicrolensTM. Presbia received FDA approval to commence the se
8/24/15 - RetroSense Therapeutics Lead Gene Therapy Candidate Gets FDA Clearance to Proceed to First-in-Human Clinical Trials
RetroSense Therapeutics LLC, a privately-held biopharmaceutical company, today announced the Company s Investigational New Drug application for RST-001 received clearance from the United States Food and Drug Administration. RetroSense Therapeutics is developing RST-001 as a first-in-class gene therapy application of optogenetics.
8/23/15 - FDA Approves 28 Additional Styles Of Allergan's Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Allergan, plc. announced that the company has received approval from the U.S. Food and Drug Administration to market 28 additional styles of Natrelle 410 silicone-filled breast implants, giving surgeons and patients more options to achieve desired outcomes. The FDA approved ex
8/23/15 - India : US FDA approval for Omeprazole delayed-release capsules received by Aurobindo Pharma [TendersInfo (India)]
Aurobindo Pharma has obtained the final approval from the US Food& Drug Administration to manufacture and market Omeprazole delayed-release capsules USP, 10 mg, 20 mg and 40 mg. The permitted ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Prilosec delayed-release capsules, 10 mg, 20 mg and 40 mg of AstraZe
8/23/15 - Sensible Medical Innovations Receives FDA 510K Clearance for its Non-Invasive Thoracic Fluid Status Monitor
KFAR NETER, ISRAEL August 24, 2015. Sensible Medical Innovations Ltd., is proud to announce that it received clearance from the U.S. Food and Drug administration for its non-invasive thoracic fluid status monitor. The Sensible product is intended for monitoring and management of patients with fluid management problems, including patients living wit
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