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 The leading web portal for pharmacy resources, news, education and careers July 29, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 29, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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7/24/14 - Boston Scientific Garners FDA Approval for REBEL Platinum Chromium Coronary Stent System [Professional Services Close - Up]
Boston Scientific has received FDA approval for the REBEL Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the treatment of coronary artery disease. The REBEL Stent System expands the Boston Scientific family of stents featuring its proprietary platinum chromium alloy and a customized stent architecture.
7/24/14 - CorMatrix Receives FDA Approval to Market ECM for Vascular Repair [Health & Beauty Close - Up]
CorMatrix Cardiovascular reported that it has received U.S. Food and Drug Administration clearance to market the CorMatrix ECM for Vascular Repair. Richard F. Neville, Professor of Surgery, Chief, Division of Vascular Surgery at George Washington University said, "CorMatrix ECM for Vascular Repair is an innovative scaffold permitting the patient's
7/24/14 - FDA Approves Flonase Allergy Relief For Sale Over-The-Counter In The United States
GlaxoSmithKline plc today announced that the U.S. Food and Drug Administration has approved Flonase Allergy Relief, containing the No. 1 prescribed allergy treatment ingredient 1, as an over-the-counter treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies. 2. Roughly 50 million people in the United States
7/24/14 - FDA Confirms Approval of Gilead's Zydelig; FDA Approves Eagle Pharmaceuticals' Ryanodex
FDA said it has approved Gilead Sciences Inc's Zydelig, a drug to treat three types of blood cancer. The FDA approved the use of Zydelig in combination with Roche AG's Rituxan for patients with relapsed chronic lymphocytic leukemia. It also approved Zydelig under a so-called accelerated approval program for relapsed follicular B-cell non-Hodgkin ly
7/24/14 - MacroGenics' DART Candidate IND for Colorectal Cancer, MGD007, Cleared to Start Enrolling Patients
MacroGenics, Inc., a clinical stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that its investigational new drug for MGD007 has been cleared by the U.S. Food and Drug Administration to proceed with the Phase
7/24/14 - Onco360 Named to Zydelig (Idelalisib) Limited Distribution Network; Zydelig is Available Immediately for Order Through Onco360
Onco360, the nation s fastest-growing independent Oncology Pharmacy and Clinical Support Services company, today announced that it has been selected to be part of the highly limited Specialty Pharmacy network of Zydelig tablets. PharMerica Corporation is a significant investor in Onco360. Zydelig has been approved by The U.S. Food and Drug Admin
7/24/14 - Philips Gets FDA 510(k) Clearance For VISIQ Ultrasound System
AMSTERDAM- Koninklijke Philips Electronics NV said it received 510 marketing clearance from U.S. Food and Drug Administration or FDA, for its innovative ultra mobile ultrasound system VISIQ. VISIQ with its transducer-plus-tablet display delivers excellent image quality, making ultrasound available anytime, in a wide range of clinical environments f
7/24/14 - Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system
Royal Philips today announced that it has received 510 clearance from the U.S. Food and Drug Administration to market its innovative ultra mobile ultrasound system, VISIQ, in the U.S. VISIQ is the first Philips ultrasound system to combine the benefits of greater mobility, performance and simplicity into a single miniaturized solution, helping cl
7/23/14 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Generic FDA Rapid Response Surveys" has been approved by the Office of Management and Budg
7/23/14 - FDA Approves Eagle Pharmaceuticals' Ryanodex For The Treatment Of Malignant Hyperthermia
Eagle Pharmaceuticals, Inc. today announced that the U. S. Food and Drug Administration has approved Ryanodex for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it wil
7/23/14 - FDA Approves Eagle Pharmaceuticals Ryanodex for the Treatment of Malignant Hyperthermia
Eagle Pharmaceuticals, Inc. today announced that the U. S. Food and Drug Administration has approved Ryanodex for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. FDA had designated Ryanodex as an Orphan Drug in August 2013. We are very pleased with today s approva
7/23/14 - FDA approves Gilead Sciences drug for 3 cancers
WASHINGTON The Food and Drug Administration on Wednesday approved a new cancer drug from Gilead Sciences Inc. to treat three types of blood cancer. The FDA has approved three other drugs for the disease in the last year: Roche's Gazyva, Janssen Pharmaceutical's Imbruvica and GlaxoSmithKline's Arzerra. The FDA approved Zydelig for leukemia based
7/23/14 - FDA Approves New Extended-release Oxycodone with Abuse-Deterrent Properties
Targiniq ER is the second ER/LA opioid analgesic with FDA- approved labeling describing the product's abuse-deterrent properties consistentwith the FDA's 2013 draft guidance for industry, Abuse-Deterrent Opioids- Evaluation and Labeling. "The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that ar
7/23/14 - FDA approves new painkiller from OxyContin maker
FDA regulators approved the drug for daily, round-the-clock pain that does not respond to other medications. The FDA notes that Targiniq can still be abused by simply swallowing the tablets, the most frequent method of painkiller abuse. The FDA has been under intense public pressure to combat the national epidemic of prescription opioid abuse.
7/23/14 - FDA Approves Zydelig For Three Types Of Blood Cancers
Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL. "In less than a year, we have seen considerable progress in the availability of treatments for chronic lymphocytic leukemia," said Richard Pazdur, M.D., director of the Office of Hematology a
7/23/14 - Protein Sciences Receives Approval from FDA for 2014/15 Formulation of Flublok Influenza Vaccine
By a News Reporter-Staff News Editor at Vaccine Weekly Protein Sciences Corporation announced that the FDA has approved the Company's strain change amendment for its seasonal influenza vaccine, Flublok. She added, "We are still accepting orders for the fall and providers are encouraged to order through our distributors FFF Enterprises and ASD Hea
7/23/14 - Review of ADHD drug approvals highlights gaps between pediatric approval process and long-term safety assessment
The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process. "Instead, we point to the need for an agenda emphasizing improved assessment of rare adverse events and long-term safety through post-marketing trials, comparative effectiveness trials and more active
7/23/14 - Spectranetics Announces FDA Clearance of Peripheral Laser Atherectomy Devices for In-Stent Restenosis
The Spectranetics Corporation today announced receipt of U.S. Food and Drug Administration 510 clearance of their peripheral atherectomy products, Turbo-Tandem and Turbo Elite , for the treatment of in-stent restenosis. "With mean lesion length at 20 centimeters, approximately one-third of the patients being re-treated for ISR and also...
7/23/14 - U.S. Food and Drug Administration Approves Gilead's Zydelig (idelalisib) for Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved Zydelig 150 mg tablets for the treatment of three B-cell blood cancers. Zydelig is indicated in combination with rituximab for patients with relapsed chronic lymphocytic leukemia for whom rituximab alone would be considered appropriate therapy and as...
7/23/14 - United States : VENITI receives FDA approval for VICI VENOUS STENT SYSTEM [TendersInfo (India)]
U.S. Food and Drug Administration has sanctioned Veniti for one of its devices that looks to treat venous disease. Veniti was approved for its Vici Venous Stent System, which is a stent that is particularly designed for veins. Veniti has utilized funds from its $9.7 million Series B funding round in June 2013 to help formulate the device that is al
7/22/14 - Access Pharmaceuticals Receives 510(K) FDA Marketing Clearance For ProctiGard?
DALLAS and NEW YORK, July 22, 2014/ PRNewswire/ ACCESS PHARMACEUTICALS, INC., a developer of new products for oncology supportive care, announced today that it has received 510 marketing clearance from the U.S. Food and Drug Administration for ProctiGard?, its novel treatment for symptomatic management of rectal mucositis. The Company indicated
7/22/14 - Cytonics Announces FDA Approval of an Investigational New Drug Application for the APIC Cell-Free System
Cytonics Corporation has announced that an Investigational New Drug application for a phase I/II clinical trial of the company's APIC Cell-Free System has been approved by the FDA. The system is indicated for the rapid preparation of concentrated protease inhibitors in plasma, specifically Alpha-2-Macroglobulin, for the treatment of mild to moderat
7/22/14 - Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders
Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, announced today that the U.S. Food and Drug Administration, or the FDA, cleared Galmed's Investigational New Drug, or IND, applicatio
7/22/14 - Halozyme Resumes Patient Enrollment And Dosing In PEGPH20 Clinical Program In Pancreatic Cancer
Halozyme Therapeutics, Inc. today announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer under the revised clinical protocol agreed to with the FDA in June. PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronid
7/22/14 - Spectral Diagnostics announces shareholder approval of its up to $18.2 million offering
/CNW/- Spectral Diagnostics Inc. today announced that at the special meeting of shareholders of the Corporation held earlier today, Shareholders overwhelmingly approved the terms of the previously announced proposed non-brokered private placement of the Corporation of up to $18.2 million. FDA approval for its lead theranostics product for the treat
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