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 The leading web portal for pharmacy resources, news, education and careers February 11, 2016
Pharmacy Choice - Pharmacy News - February 11, 2016

Pharmacy News

Today's Pharmaceutical and Pharmacy News
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FDA News
2/11/16 - Guerbet receives FDA 510k clearance for the OptiOneâ?¢ Single-Head Contrast Delivery System
The US clearance confirms Guerbet's international focus in providing innovative imaging solutions to serve wider customer needs. Guerbet will present the injector at the upcoming European Congress of Radiology. "We are extremely pleased to announce the availability of this newest injector system, as we believe that it offers additional flexibility
2/11/16 - Lannett Receives FDA Approval For Temozolomide Capsules
--Lannett Company, Inc. today announced that its wholly owned subsidiary, Kremers Urban Pharmaceuticals Inc., has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug Temod
2/11/16 - NAFDAC Approves Local Production of Life Saving Drugs
The National Agency for Food and Drug Administration and Control, NAFDAC, has approved the production of four United Nations life saving commodities for women and children. Paul Orhii, who spoke at a two-day Common Technical Document, CTD, workshop in Lagos, said, Nigerians now have improved access to locally produced safe, efficacious and affordab
2/11/16 - Philips secures 510(k) clearance to market new patient monitoring solution to bring bedside quality monitoring to the MR suite
ANDOVER, MA.-- Royal Philips today announced the Expression MR400, a new technology that monitors patients undergoing magnetic resonance imaging, has received 510 clearance from the U.S. Food and Drug Administration. The MR400 provides ICU-comparable, bedside quality monitoring in the MR suite for all patients, including those with serious medical.
2/11/16 - Zimmer Biomet Announces FDA Clearance for Unite3Dâ?¢ Bridge Fixation System
WARSAW, Ind., Feb. 11, 2016/ PRNewswire/-- Zimmer Biomet Holdings, a global leader in musculoskeletal healthcare, is pleased to announce that the Company has received 510 clearance from the U.S. Food and Drug Administration for the Unite3Dâ?¢ Bridge Fixation System, a groundbreaking 3 D-printed technology designed to offer stability in foot and ank
2/10/16 - American College of Rheumatology Encourages Safe Adoption of Biosimilars During FDA Public Hearing on CT-P13, a Proposed Biosimilar for Infliximab (Remicade)
--During a public meeting held Tuesday by the Food and Drug Administration' s Arthritis Advisory Committee to review the license application of CT-P13, the American College of Rheumatology provided recommendations for policy guidelines to implement as the committee decides whether to license additional biosimilars for sale in the U.S. If approved,

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