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 The leading web portal for pharmacy resources, news, education and careers December 3, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - December 3, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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11/29/16 - Samsung Showcases a Wide Range of Latest Medical Imaging Solutions At RSNA 2016
The GM85 Digital Radiography system which received 510 FDA clearance November 17 for the US market, at the Radiological Society of North America 2016 Annual Meeting at McCormick Place in Chicago. "Celebrating our fifth year participating at RSNA, the largest radiology meeting, we would like to thank our valued customers and partners for their ongo
11/29/16 - Toshiba Medicals Fully Integrated Model-Based Iterative CT Reconstruction Receives FDA Clearance [Qatar Tribune]
Marcus Chen, director, Cardiovascular CT, National Heart, Lung and Blood Institute, National Institutes of Health, who was part of the beta testing for FIRST. With FIRST, we saw a way to take industry-changing technology beyond the research setting and help our clinical partners use it to benefit their patients, said Dominic Smith, senior director,
11/28/16 - Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Armodafinil Tablets (CIV) in 50mg, 150mg and 250 mg strengths (Nuvigil)
Breckenridge Pharmaceutical, Inc. announced today that it has launched its ANDA for Armodafinil tablets in 50 mg, 150 mg and 250 mg strengths on November 28, 2016, after having received final approval by FDA. Armodafinil tablets is a generic version of Nuvigil by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.
11/28/16 - FDA approves Intrarosa for postmenopausal women experiencing pain during sex
By a News Reporter-Staff News Editor at Clinical Trials Week The U.S. Food and Drug Administration approved Intrarosa to treat women experiencing moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy, due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, whi
11/28/16 - FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions
Relypsa, Inc., a Vifor Pharma company, today announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application with important updates to the label of Veltassa for oral suspension. These important updates are based on our positive data, which showed there is a low risk for drug-drug interactions with Veltassa
11/28/16 - FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions
The updated US label for Veltassa recommends patients take Veltassa at least 3 hours before or 3 hours after other oral medications Change can provide doctors greater flexibility in prescribing Veltassa to patients Approval reinforces potential of Veltassa as a key platform of additional growth for Vifor Pharma Vifor Pharma to make ne
11/28/16 - Global Health Solutions Announces 510k FDA Approval of PolyPlex Wound Dressing
Global Health Solutions has announced 510 k FDA approval of PolyPlex Wound Dressing, a first of its kind, petrolatum based topical gel indicated for acute and chronic wound management. PolyPlex Wound Dressing employs Global Health Solutions' proprietary PermaFusion? delivery system, first employed in its initial product offering, CurX Antimicro
11/28/16 - Imperial Innovations Portfolio Company Drug Passed For Clinical Study
Imperial Innovations said the TopiVert's investigational application for its TOP1630 opthalmic solution has been approved by the US Food and Drug Administration, allowing it to enter the clinic in the US in a proof-of-concept Phase I/Phase IIa study. TOP1630 will TopiVert's second compound to enter the clinic, following TOP1288, which completed its
11/28/16 - Lannett Announces Approval For Metaxalone Tablets USP, 800 Mg
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Metaxalone Tablets USP, 800 mg, the therapeutic equivalent to the reference listed drug, Skelaxin of King Pharmaceuticals, Inc. According to IMS, total U.S. sales for the 12 months ended Septemb
11/28/16 - Natco receives US FDA approval for generic budesonide capsule [Tripoli Post, The (Libya)]
Natco Pharma Limited on Thursday announced that it has received final approval from the US Food and Drug Administration for generic version of budesonide capsule 3 mg. Natco and its marketing partner Alvogen plan to launch this product in the US immediately. According to IMS Health, Entocort EC capsule and its generic versions had US sales of appro
11/28/16 - New Test for Inflammatory Bowel Disease Cleared by FDA
By a News Reporter-Staff News Editor at Pharma Business Week Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, is pleased to announce the US Food and Drug Administration clearance of QUANTA Lite Calprotectin Extended Range, an assay which aids in the diagnosis of Inflammatory Bowel Di
11/28/16 - Phase 3 Study Results Supporting U.S. FDA and European Commission Approvals of STELARA in the Treatment of Moderately to Severely Active Crohn's...
Phase 3 Study Results Supporting U.S. FDA and European Commission Approvals of STELARA in the Treatment of Moderately to Severely Active Crohn's Disease Published in The New England Journal of Medicine. By a News Reporter-Staff News Editor at Pharma Business Week Results from three pivotal Janssen Research& Development, LLC- sponsored Phase 3 stu
11/28/16 - Rocky Mountain Cancer Centers First In Region to Offer Newly Approved Gallium DOTATATE PET/CT for Neuroendocrine Tumors
By a News Reporter-Staff News Editor at Clinical Trials Week Rocky Mountain Cancer Centers, a practice in The US Oncology Network, is the first in the Rocky Mountain region, and one of only a handful of sites in the United States, to offer the newly approved Ga-68 DOTATATE PET/CT for patients with neuroendocrine tumors. The U.S. Food and Drug Adm
11/28/16 - Samsung Showcases FDA-Cleared GM85 Mobile Digital Radiography System at RSNA 2016 [Seven Days (United Arab Emirates)]
Samsung Electronics showcases the GM85 Digital Radiography system which received 510 FDA clearance November 17 for the US market, at the Radiological Society of North America 2016 Annual Meeting at McCormick Place in Chicago. Celebrating our fifth year participating at RSNA, the largest radiology meeting, we would like to thank our valued customers
11/28/16 - ZDi Solutions, LLC Receives FDA Approval for Patented Proton Therapy & Conventional Radiation Therapy Positioning Devices
By a News Reporter-Staff News Editor at Pharma Business Week ZDi Solutions, LLC announced that it has received approval from the U.S. Food and Drug Administration for its Z-System? patient positioning devices for proton therapy and conventional radiation therapy. Said John Hawkins, CEO, " FDA approval was the next step in our launch process, an
11/27/16 - Samsung Showcases FDA-Cleared GM85 Mobile Digital Radiography System at RSNA 2016
Samsung Electronics showcases the GM85 Digital Radiography system which received 510 FDA clearance November 17 for the US market, at the Radiological Society of North America 2016 Annual Meeting at McCormick Place in Chicago. Samsung Electronics showcases the GM85, a premium mobile digital radiography system at the Radiological Society of North...
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