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 The leading web portal for pharmacy resources, news, education and careers September 17, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 17, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 53     Next >>     Go To Page:

9/17/14 - FDA approves MOVANTIK (naloxegol) tablets C-II for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain
Release date- 16092014- AstraZeneca today 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. Briggs Morrison, Executive Vice...
9/17/14 - GE Healthcare Announces FDA Approval of SenoClaire, New Breast Imaging with 3D Tomosynthesis Solution
By a News Reporter-Staff News Editor at Biotech Week GE Healthcare announced the FDA approval of SenoClaire*, GE's new breast tomosynthesis solution designed with a three-dimensional imaging technology. Daniel Kopans, Senior Radiologist, Breast Imaging Division Department of Radiology, Massachusetts General Hospital. Murray Rebner MD, FACR, Profe
9/16/14 - Advanced Bionics Launches World's First Waterproof Case for Cochlear Implant Recipients
Advanced Bionics, a global leader in cochlear implant technology and a company of the Sonova Group, announced today that the AquaCase?* container has obtained FDA approval and will be commercially available in the United States starting on November 3, 2014, following its successful launch in Europe and Canada earlier this year. The waterproof Aqu
9/16/14 - AstraZeneca Says US FDA Approves Opioid-Induced Constipation Treatment
LONDON- AstraZeneca PLC Tuesday said the US Food and Drug Administration has approved its MOVANTIK tablets C-II for the treatment of opioid-induced constipation, in adult patients with chronic, non-cancer pain. According to AstraZeneca, opioids play an important role in chronic pain relief and millions of patients are treated with them in the US ea
9/16/14 - CivaTech Oncology Gets FDA Approval for CivaSheet Brachytherapy Device [Manufacturing Close - Up]
CivaTech Oncology has received FDA clearance on its bioabsorbable, planar radiation device. Brian J. Moran, Medical Director of Chicago Prostate Center believes the CivaSheet "potential could be huge. "We are very excited about the beneficial impact this can have for all of the patients whom are candidates for this new treatment option," said Civa
9/16/14 - FDA Approves MOVANTIK (naloxegol) Tablets
FDA APPROVES MOVANTIK? (naloxegol) TABLETS C-II FOR THE TREATMENT OF OPIOID-INDUCED CONSTIPATION IN ADULT PATIENTS WITH CHRONIC NON-CANCER PAIN AstraZeneca today announced that the US Food and Drug Administration (FDA) approved MOVANTIK? (naloxegol) tablets C-II as the first once -daily oral peripherally-acting mu-opioid receptor antagonist (PA
9/16/14 - FDA Approves Movantik For Opioid-Induced Constipation
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 today approved Movantik, an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain. "Supportive care products such as Movantik can lessen the constipating side effec
9/16/14 - FDA Approves MOVANTIK? (naloxegol) Tablets C-II for the Treatment of Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
AstraZeneca today 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. The FDA approval of MOVANTIK provides a new treatment o
9/16/14 - FDA Approves MOVANTIK? (naloxegol) Tablets For The Treatment Of Opioid-Induced Constipation In Adult Patients With Chronic Non-Cancer Pain
Nektar Therapeutics reported today that partner AstraZeneca today announced that the US Food and Drug Administration approved MOVANTIK? tablets 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.
9/16/14 - FDA Approves the Use of a Needle-Free Injection Device to Administer the Influenza Vaccine
Eternity Healthcare Inc., a medical device and diagnostic company with advanced technologies using the Needle-Free Injection system announced today that its competitor company, PharmaJet Inc., has received FDA clearance to use a Needle-Free Injection device to administer the influenza vaccine to the public. Dr. Salari, C.E.O. of Eternity Healt
9/16/14 - FDA Grants Approval to New Xtandi Indication [Professional Services Close - Up]
Medivation and Astellas Pharma said that the U.S. Food and Drug Administration has approved a new indication for the use of Xtandi capsules to treat patients with metastatic castration-resistant prostate cancer. "The FDA's priority review and approval of this new indication for Xtandi now enables the use of an important therapy by patients with me
9/16/14 - FDA Warns Against Non-approved Dermal Filler
"Expression" was originally put on the market to be used as an intra-nasal splint following rhinoplasty, and was never approved by the FDA for use as a dermal filler. "Ethical cosmetic dermatologists should only use FDA approved fillers, and be upfront and honest about potential side effects." "There are a wide variety of outstanding FDA approved
9/16/14 - Lannett Reports FDA Approval of Oxycodone Hydrochloride Oral Solution [Health & Beauty Close - Up]
Lannett Company has received approval from the U.S. Food and Drug Administration of its abbreviated new drug application for oxycodone hydrochloride oral solution USP, 100 mg per 5 mL. "Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL, is an important and long awaited addition to our pain management franchise and represents our fourth pr
9/16/14 - Nektar says FDA clears constipation drug Movantik
British drugmaker AstraZeneca PLC will market the drug, and it has also filed for regulatory approval in the European Union and Canada. The San Francisco company said Movantik will be available to patients in the first half of 2015. AstraZeneca will conduct a study to evaluate the drug's cardiovascular side effects. AstraZeneca stock fell 9 cents t
9/16/14 - Trice Medical Receives FDA 510(k) Clearance for mi-eye
King of Prussia, PA, September 16, 2014 Trice Medical?, a private diagnostics company focused on micro invasive technologies, announced that it received 510 regulatory clearance from the United States Food and Drug Administration for its new device, mi-eye?. Jeff O'Donnell, Chairman and CEO of Trice Medical, commented, "The FDA clearance of
9/15/14 - Cochlear Announces the FDA Approval of True 2.4 GHz Wireless Connectivity With the Cochlear? Nucleus 6 Sound Processor
Cochlear Limited, the global leader in implantable hearing solutions, announced today that the US Food and Drug Administration approved the use of 2.4 GHz wireless connectivity with the Cochlear? Nucleus 6 Sound Processor. The Cochlear Wireless portfolio includes three accessories designed to help bring Nucleus 6 System recipients closer to
9/15/14 - Esaote Receives FDA Clearance for Its Compact MyLab Six Ultrasound System
By a News Reporter-Staff News Editor at Pharma Business Week Esaote North America announced that its new MyLab Six ultrasound system has received 510 clearance from the U.S. Food and Drug Administration and is now available for sale in the United States. "Today's practices need ultrasound systems that deliver high quality images across a broad s
9/15/14 - FDA Approves Baxter's HYQVIA for Treatment of Adu
DEERFIELD, Ill. and SAN DIEGO, Calif.- Baxter International Inc. and Halozyme Therapeutics, Inc., today announced that the United States Food and Drug Administration approved Baxter's subcutaneous treatment for adult patients with primary immunodeficiency, HYQVIA. Since each person with PI responds differently to treatment, having options that meet
9/15/14 - FDA Approves Baxter's HYQVIA for Treatment of Adults with Primary Immunodeficiency
DEERFIELD, Ill. and SAN DIEGO, Calif.- Baxter International Inc. and Halozyme Therapeutics, Inc., today announced that the United States Food and Drug Administration approved Baxter's subcutaneous treatment for adult patients with primary immunodeficiency, HYQVIA. Since each person with PI responds differently to treatment, having options that meet
9/15/14 - FDA Approves Baxter's RIXUBIS [Coagulation Factor IX (Recombinant)] for Treatment of Children with Hemophilia B
DEERFIELD, Ill.- Baxter International Inc. today announced that the United States Food and Drug Administration has approved RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. RIXUBIS was the first recombinant factor IX approved for routine prophylaxis
9/15/14 - FDA Approves Baxter's RIXUBIS For Treatment Of Children With Hemophilia B
Baxter International Inc. today announced that the United States Food and Drug Administration has approved RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. RIXUBIS was the first recombinant factor IX approved for routine prophylaxis and control of...
9/15/14 - FDA Approves Baxter's RIXUBIS [Coagulation Factor IX (Recombinant)] for Treatment of Children with Hemophilia B
Baxter International Inc. today announced that the United States Food and Drug Administration has approved RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. RIXUBIS was the first recombinant factor IX approved for routine prophylaxis and control of...
9/15/14 - FDA Approves New Indication for the Use of XTANDI (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer [Health & Beauty Close - Up]
Astellas Pharma and Medivation said that the U.S. Food and Drug Administration has approved a new indication for the use of XTANDI capsules to treat patients with metastatic castration-resistant prostate cancer. "The FDA's priority review and approval of this new indication for XTANDI now enables the use of an important therapy by patients with me
9/15/14 - FDA Approves New Styles Of The MENTOR MemoryShape Silicone Breast Implant
Mentor Worldwide LLC, the U.S. market leader in breast aesthetics, today 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 commitment to meet the needs of plastic surgeons
9/15/14 - InnoPharma Announces FDA Approval of Decitabine for Injection, a Generic Version of DACOGEN
By a News Reporter-Staff News Editor at Pharma Business Week InnoPharma, Inc. announced the approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for decitabine for injection, a generic version of Eisai Inc.' s DACOGEN . InnoPharma developed the generic formulation of decitabine for injection and entered i
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