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 The leading web portal for pharmacy resources, news, education and careers September 5, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 5, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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9/4/15 - AstraZeneca - US FDA approves expanded indication for BRILINTA to include long-term use in patients with a history of heart attack
Release date- 03092015- AstraZeneca today announced that the US Food and Drug Administration has approved BRILINTA tablets at a new 60 mg dose to be used in patients with a history of heart attack beyond the first year. BRILINTA is an oral antiplatelet treatment that works by inhibiting platelet activation and was first approved by the FDA in July
9/4/15 - AstraZeneca heart disease drug gets FDA approval at 60mg
AstraZeneca received a much-needed boost when its blood-thinning drug, Brilinta, a potential blockbuster, was approved by the US health regulator for wider use. Antoine Yver, head of oncology in global medicines development at AstraZeneca, said: AZD9291 is moving through clinical development with unprecedented speed, and was recently granted US
9/4/15 - AstraZeneca heart disease drug gets wider FDA approval
AstraZeneca received a much-needed boost when its blood-thinning drug, Brilinta, a potential blockbuster, was approved by the US health regulator for wider use. Brilinta is one of the big earners AstraZeneca is counting on to offset falling sales from older bestsellers as they come off patent, such as Nexium and Crestor. Brilinta has had a bumpy ri
9/4/15 - AstraZeneca Says US FDA Approves Expanded Indication For Brilinta
LONDON- AstraZeneca PLC late on Thursday said the US Food and Drug Administration has approved its Brilinta tablets at a new 60 miligram dose to be used in patients with a history of heart attacks beyond the first year of treatment. The FTSE 100 drugmaker said that with the expanded indication Brilinta is now approved as a treatment for reducing th
9/4/15 - Cosmo Pharma Press release: FDA approves SIC
FDA approves Cosmo's submucosal injectable composition SIC 8000. Luxembourg, Luxembourg- September 4, 2015- Cosmo Pharmaceuticals S.p.A. announced today that the FDA has approved its request for marketing authorization of SIC 8000, its submucosal injectable composition.. Alessandro Della Ch, CEO of Cosmo Pharmaceuticals, commented: "I am very ple
9/4/15 - FDA approves new orphan drug to treat rare autosomal recessive disorder
FDA approves new orphan drug to treat rare autosomal recessive disorder. Today, the U.S. Food and Drug Administration approved Xuriden, the first FDA- approved treatment for patients with hereditary orotic aciduria. "Today's approval and rare pediatric disease priority review voucher underscore the FDA's commitment to making treatments available t
9/4/15 - Mitralign Gets FDA Approval for Percutaneous Tricuspid Repair Early Feasibility Study [Health & Beauty Close - Up]
Mitralign reported that the U.S. Food and Drug Administration has granted Investigational Device Exemption approval for the Company to conduct an early feasibility study to examine its Percutaneous Tricuspid Valve Annuloplasty System. "Percutaneous repair of the tricuspid valve represents one of the largest remaining unmet needs in the structural.
9/4/15 - U.S. FDA Grants Priority Review to Janssen for Daratumumab as a Treatment for Multiple Myeloma
Daratumumab, an investigational human anti-CD38 monoclonal antibody, received Breakthrough Therapy Designation from the FDA for this patient population in May 2013. With today's announcement, the FDA has assigned a Prescription Drug User Fee Act target date of March 9, 2016 to render a decision on the daratumumab application. "Daratumumab has the.
9/4/15 - US FDA approves expanded indication for BRILINTA to include long-term use in patients with a history of heart attack
AstraZeneca today announced that the US Food and Drug Administration has approved BRILINTA tablets at a new 60 mg dose to be used in patients with a history of heart attack beyond the first year. BRILINTA is an oral antiplatelet treatment that works by inhibiting platelet activation and was first approved by the FDA in July 2011 on the basis of
9/4/15 - US FDA OKs Initiation of ViroMed's VM202 for Phase III Clinical Study of Chronic Non-Healing Ischemic Diabetic Foot Ulcer [Health & Beauty Close - Up]
ViroMed Co. reported that the company has received an approval from the US FDA to launch a pivotal Phase III clinical trial utilizing VM202, a proprietary DNA based biopharmaceutical, for chronic non-healing ischemic diabetic foot ulcers. The company said this is the first gene therapy trial specifically targeting ulcers which affects millions of p
9/4/15 - US FDAAPPROVES EXPANDEDINDICATIONFOR BRILINTA TO INCLUDE LONG-TERM USE IN PATIENTSWITHAHISTORYOFHEART ATTACK
AstraZeneca today announced that the US Food and Drug Administration has approved BRILINTA tablets at a new 60 mg dose to be used in patients with a history of heart attack beyond the first year. BRILINTA is an oral antiplatelet treatment that works by inhibiting platelet activation and was first approved by the FDA in July 2011 on the basis of
9/3/15 - Focus Diagnostics Receives FDA Clearance to Add Genital Swab Claim to Moderate Complexity Simplexa? HSV 1 & 2 Direct Molecular Test
MADISON, N.J. and CYPRESS, Calif., Sept. 3, 2015/ PRNewswire/ Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that its Focus Diagnostics products business has received FDA 510 clearance to add the genital swab claim to its Simplexa HSV 1& 2 Direct molecular test on the Integrated Cycler. In 2000
9/3/15 - Lifeline Scientific Gets China Approval As Interim Revenue Nudges Up
LONDON- Transplant technology company Lifeline Scientific PLC on Thursday said it has secured regulatory approval for its lead product in China and said its first half revenue has increased in the first half. Lifeline said the Chinese Food and Drug Administration has formally approved its lead product, the LifePort Kidney Transporter, and all relat
9/3/15 - Teleflex Receives FDA Clearance for the ARROW Triple Lumen Pressure Injectable Acute Hemodialysis Catheter
Teleflex Incorporated, a leading global provider of medical technologies for critical care and surgery, has announced it has received FDA 510 clearance to market its ARROW Triple Lumen Pressure Injectable Acute Hemodialysis Catheter. Teleflex is committed to partnering with healthcare facilities to reduce vascular access related complications.
9/3/15 - TESARO Announces U.S. FDA Approval of VARUBI(TM) (rolapitant) for Nausea and Vomiting Associated With Cancer Chemotherapy [Moj News Agency (Iran)]
-TESARO, Inc., an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved VARUBI? in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limit
9/3/15 - US FDA Approves Expanded Indication For BRILINTA To Include Long-Term Use In Patients With A History Of Heart Attack
AstraZeneca today announced that the US Food and Drug Administration has approved BRILINTA tablets at a new 60 mg dose to be used in patients with a history of heart attack beyond the first year. BRILINTA is an oral antiplatelet treatment that works by inhibiting platelet activation and was first approved by the FDA in July 2011 on the basis o
9/3/15 - Zeiss Reports FDA 510(k) Clearance of OCT Angiography Technology [Health & Beauty Close - Up]
Zeiss Medical Technology reported that its AngioPlex OCT Angiography is the first such technology to receive 510 clearance from the U.S. Food and Drug Administration. With a single additional OCT scan that takes just seconds on the CIRRUS HD-OCT system from Zeiss, the company said, ophthalmologists can now utilize optical coherence tomography image
9/2/15 - Allergan Announces FDA Approval of Updated Label for TEFLARO (ceftaroline fosamil)
Allergan plc today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application to update the label for TEFLARO for the treatment of adult patients with acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. "The new clinical data in the TEFLARO label will
9/2/15 - Allergan: FDA Approves Updated Label For TEFLARO
WASHINGTON- Allergan plc announced U.S. FDA has approved the company's supplemental new drug application to update the label for TEFLARO for the treatment of adult patients with acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. The approved label contains new clinical data from two ABSSSI trials that...
9/2/15 - Bristol-Myers: FDA Accepts SBLA For Opdivo, Grants Priority Review
The projected FDA action date is January 2, 2016. Opdivo is a programmed death-1 or PD-1 immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications. The FDA has also granted this application priority review, and Opdivo Breakthrough Therapy Designation for this indication, marking the third indicat
9/2/15 - FDA Approves Pediatric Indication for EMEND (aprepitant) Capsules in Combination with Other Antiemetic Agents
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for EMEND capsules, a substance P/neurokinin 1 receptor antagonist. With this expanded indication, EMEND capsules are now approved for use in combination with other antiemetic agent
9/2/15 - Memphis-based Wright Medical wins FDA approval of Augment Bone Graft [The Commercial Appeal, Memphis, Tenn.]
Sept. 01 Long-sought government approval of a bone graft product on Tuesday achieved a key part of Wright Medical Group Inc.' s blueprint for fast growth as a Memphis medical device maker. "The FDA approval of Augment marks a capstone achievement that demonstrates the strength of our science and provides a breakthrough therapeutic option as an a
9/2/15 - Merck : FDA Approves SNDA For EMEND Capsules
WHITEHOUSE STATION- Merck& Co. Inc. announced that the U.S. Food and Drug Administration or FDA has approved a supplemental New Drug Application or sNDA for EMEND or aprepitant capsules, a substance P/neurokinin 1 or NK1 receptor antagonist. With this expanded indication, EMEND capsules are now approved for use in combination with other antiemetic
9/2/15 - Newly Approved Epiduo Forte adapalene and benzoyl peroxide Gel, 0.3%/2.5% Prescription Treatment Now Available for Acne Patients Nationwide
By a News Reporter-Staff News Editor at Biotech Week Galderma Laboratories, L.P. announced that Epiduo Forte Gel, 0.3%/ 2.5%, is now available in retail pharmacies nationwide and in Puerto Rico. It was recently approved by the U.S. Food and Drug Administration for the once-daily, topical treatment of acne vulgaris. Patients with significant ac
9/2/15 - Novocure files for $300m Nasdaq IPO [Globes, Tel Aviv, Israel]
Sept. 02 Novocure, which develops and markets a medical device for treatment of brain tumors using electric fields, yesterday submitted a prospectus for an IPO on Nasdaq. Novocure's product, which has been approved for marketing by the US Food and Drug Administration following a comprehensive clinical trial in 2011, is designed to treat Glioblast
Articles(s): 1 - 25 of 44     Next >>     Go To Page:


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