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 The leading web portal for pharmacy resources, news, education and careers September 29, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 29, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 64     Next >>     Go To Page:

9/29/16 - Allergan Issues Statement on Namenda XR Patent Litigation Following Announcement of ANDA Approvals
Allergan plc, today issued the following statement regarding ongoing litigation on patents related to NAMENDA XR extended release capsules following announcement of FDA final ANDA approval by Lupin. "As announced on September 10, 2015, Allergan's Forest Laboratories subsidiaries and its licensors announced a settlement agreement regarding the
9/29/16 - Antipsychotic ABILIFY Gains Approval in Japan for the Additional Indication of Irritability Associated with Pediatric Autism Spectrum Disorder
It is reported there are approximately 100,000 patients in Japan with autism spectrum, which in some cases can manifest as episodes of aggression, temper tantrums, self-harm, and other behavioral symptoms. ABILIFY received approval from the U.S. FDA in 2009 for use in pediatric patients with irritability associated with autism disorders and in Japa
9/29/16 - AstraZeneca Gets US Approval For Tagrisso Companion Diagnostic Test
LONDON- AstraZeneca PLC said Thursday the US Food and Drug Administration has approved a blood-based companion diagnostic for non-small cell lung cancer treatment Tagrisso. AstraZeneca said the approval provides a new, non-invasive option to identify patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer, ensuring that...
9/29/16 - Bucks County firm gets FDA approval for low-dose weight-reduction medicine [Cyprus Mail]
A low-dose version of a weight-loss medicine that`s been around more than 50 years has been approved by the Food and Drug Administration to be manufactured and sold by a Bucks County generic-drug maker. "The feedback we were getting from patients was they made it through breakfast and lunch, but were hungry again around dinnertime or late in the d
9/29/16 - Bucks County firm gets FDA approval for low-dose weight-reduction medicine [Philly.com]
Sept. 29 A low-dose version of a weight-loss medicine that's been around more than 50 years has been approved by the Food and Drug Administration to be manufactured and sold by a Bucks County generic-drug maker. "The feedback we were getting from patients was they made it through breakfast and lunch, but were hungry again around dinnertime or la
9/29/16 - FDA APPROVES MIRACLE DRUG FOR CAVITIES
WAYNE An FDA approved cavity-fighting liquid, silver diamine fluoride which has been used in Japan for decades, is now FDA approved and available here in the United States. SDF is a clinically applied fluoride treatment used to stop cavities and prevent their further progression. "It's a wonder drug," says Dr. Fine of Fine Dental Care in Wayne.
9/29/16 - FDA Grants Roche Label Extension for the cobas EGFR Mutation Test v2 for use with Plasma as a Companion Diagnostic for TAGRISSO?
Roche today announced that the U.S. Food and Drug Administration has approved a label extension of the cobas EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca's non-small cell lung cancer therapy TAGRISSO?. On June 1 st, 2016, the FDA granted approval of the cobas EGFR Mutation Test v2, making it
9/29/16 - Medtronic gets FDA approval for automated insulin delivery device [Star Tribune (Minneapolis)]
Medtronic PLC's MiniMed 670 G "hybrid closed-loop" system received approval from the FDA just three months after the Minnesota- run device maker submitted its premarket application for approval. "The MiniMed 670 G hybrid closed loop system, often referred to as an' artificial pancreas,' is intended to adjust insulin levels with little or no input
9/29/16 - Medtronic Receives FDA Clearance of TrailBlazer Angled Peripheral Support Catheter [Tripoli Post, The (Libya)]
DUBLIN- September 28, 2016- Medtronic plc today announced that the U.S. Food and Drug Administration has cleared the TrailBlazer (TM) angled support catheter for use in the peripheral vascular system. FDA clearance was received on September 23, 2016. "Medtronic is committed to providing physicians with meaningful innovations and therapy choices to
9/29/16 - Pernix Therapeutics Announces Distribution of TREXIMET 10/60 mg (sumatriptan 10mg and naproxen sodium 60 mg) Dose For Use in Pediatric Patients [Khaleej Times (United Arab Emirates)]
-Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company with a focus on Pain and CNS conditions, today announced the distribution of TREXIMET 10/ 60 mg to wholesalers has begun. TREXIMET received U.S. Food and Drug Administration approval for use in the pediatric population 12 years of age and older in May 2015; however, this formul
9/29/16 - US FDA Approves TAGRISSO (osimertinib) Blood-Based T790M Companion Diagnostic Test
AstraZeneca today announced that the US Food and Drug Administration has approved a blood-based companion diagnostic for TAGRISSO . The companion diagnostic for TAGRISSO is the only FDA- approved and clinically validated companion diagnostic test that uses either tissue or a blood sample to confirm the presence of a T790M mutation in patients wit
9/29/16 - Vertex Says FDA Approves ORKAMBI; Cuts 2016 ORKAMBI Revenue Guidance
CAMBRIDGE- Vertex Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration approved ORKAMBI for use in children with cystic fibrosis or CF ages 6 through 11 who have two copies of the F508del mutation. Vertex also lowered its guidance for 2016 ORKAMBI revenues to a range of $950 million to $990 million. With today's approval, appro
9/28/16 - Abbott Receives FDA Approval For FreeStyle Libre Pro System
NORTH CHICAGO- Abbott announced the U.S. FDA has approved the company's FreeStyle Libre Pro system, a continuous glucose monitoring system for healthcare professionals to use with their patients with diabetes. The system is designed to empower healthcare professionals to provide better diabetes management for diabetes patients. Abbott recently...
9/28/16 - Abbott Receives FDA Approval for the FreeStyle Libre Pro? System, a Revolutionary Diabetes Sensing Technology for Healthcare Professionals to Use with Their Patients
ABBOTT PARK, Ill., Sept. 28, 2016/ PRNewswire/ Abbott today announced that the U.S. Food and Drug Administration has approved the company's FreeStyle Libre Pro system, a revolutionary continuous glucose monitoring system for healthcare professionals to use with their patients with diabetes. FreeStyle Libre Pro system is designed to empower health
9/28/16 - Aesthetic Lasers Market Is Forecasted To Grow At A CAGR of Around 15.5% By 2024: Hexa Reports
In April 2016, Oculus Innovative Sciences, Inc. received the FDA approval for Microcyn-based Lasercyn Gel, intended for post-non-ablative laser therapy procedures management. The "Global Aesthetic Lasers Market" is expected to reach USD 1.8 billion by 2024, according to a new report by Hexa Reports. For instance, in 2014, Cutera invested USD 10.5 m
9/28/16 - Bucks County firm gets FDA approval for low-dose weight-reduction medicine [Philly.com]
Sept. 28 A low-dose version of a weight- loss medicine that's been around for more than 50 years has been approved by the Food and Drug Administration to be manufactured and sold by a Bucks County generic drug maker. "The feedback we were getting from patients was they made it through breakfast and lunch, but were hungry again around dinner time
9/28/16 - FDA approves first automated insulin delivery device for type 1 diabetes
The U.S. Food and Drug Administration today approved Medtronic's MiniMed 670 G hybrid closed looped system, the first FDA- approved device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. "The FDA is dedicated to making technologies available tha
9/28/16 - Kitov Pharma jumps on osteoarthritis trial success [Globes, Tel Aviv, Israel]
The trial's success brings the company one step closer to applying for a final FDA marketing approval. In August, the company received an FDA patent approval for this drug, which will enable it to market it exclusively in the US until May 22, 2029. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer said, "We are pleased with the r
9/28/16 - Medtronic Receives FDA Approval for World's First Hybrid Closed Loop System for People with Type 1 Diabetes
The MiniMed 670 G System Features the Company's Most Advanced SmartGuard (TM) Algorithm To-Date DUBLIN- Sept. 28, 2016- Medtronic plc, the global leader in medical technology, today announced it has received U.S. Food and Drug Administration approval of its MiniMed 670 G system- the first Hybrid Closed Loop insulin delivery system approved an
9/28/16 - Medtronic Receives FDA Clearance of TrailBlazer Angled Peripheral Support Catheter
TrailBlazer Angled Support Catheter Broadens Medtronic's Leading Peripheral Options Adding Full Spectrum of Angled Resources to Meet Provider Needs DUBLIN- September 28, 2016- Medtronic plc today announced that the U.S. Food and Drug Administration has cleared the TrailBlazer (TM) angled support catheter for use in the peripheral vascular system.
9/28/16 - Merrimack to Present Final Results of Phase 3 NAPOLI-1 Study at the European Society for Medical Oncology 2016 Congress
Merrimack Pharmaceuticals, Inc. today announced it will present six posters from its systems-biology derived antibody engineering and nanotherapeutic portfolios at the European Society for Medical Oncology 2016 Congress, October 7 11, 2016 in Copenhagen, Denmark. Final results of NAPOLI -1: A Phase 3 study of nal-IRI 5- fluorouracil and leu
9/28/16 - Nevada Heart And Vascular Center Announces Partnership With Desert Springs Hospital Offering First-Of-Its-Kind Naturally Dissolving Heart Stent For Patients With Coronary Artery Disease
On Tuesday, September 27, Nevada Heart and Vascular Centers' Board Certified Interventional Cardiologist Rafael Valencia M.D., F.A.C.C., implanted a patient with the world's first FDA- approved dissolving heart stent. Today is a great example of how our medical community, in particular the physicians of Nevada Heart and Vascular Center and the de
9/28/16 - U.S. Food and Drug Administration Approves ORKAMBI (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration approved ORKAMBI for use in children with cystic fibrosis ages 6 through 11 who have two copies of the F508del mutation. With today s approval, approximately 11,000 people with CF are eligible for treatment with ORKAMBI in the United States.
9/27/16 - Aesthetic Lasers Market Is Forecasted To Grow At A CAGR of Around 15.5% By 2024: Hexa Reports
"Get key Market Research Reports and Insightful Company Profiles" In April 2016, Oculus Innovative Sciences, Inc. received the FDA approval for Microcyn-based Lasercyn Gel, intended for post-non-ablative laser therapy procedures management The " Global Aesthetic Lasers Market" is expected to reach USD 1.8 billion by 2024, according to a new report
9/27/16 - Asterias Biotherapeutics Announces Dosing of First Patient in New SCiSTAR Clinical Trial Cohort Testing AST-OPC1 in an Expanded Cervical Spinal Cord Injury Patient Population
Asterias Biotherapeutics, Inc., a biotechnology company pioneering the field of regenerative medicine, today announced that the first patient with incomplete AIS-B cervical spinal cord injury was successfully dosed with 10 million cells of AST-OPC1 in the SCiSTAR clinical trial at Shepherd Center in Atlanta. The company recently received FDA clea
Articles(s): 1 - 25 of 64     Next >>     Go To Page:


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