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 The leading web portal for pharmacy resources, news, education and careers January 22, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - January 22, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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1/22/18 - Baxter Announces U.S. FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin
Baxter International Inc., a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration approval of Bivalirudin in 0.9 percent Sodium Chloride Injection. "The approval of bivalirudin demonstrates how Baxter brings its innovative technologies together with medicines in ways that help promote..
1/22/18 - Baxter Announces U.S. FDA Approval of Ready-To-Use Cardiovascular Medication Bivalirudin; First presentation of bivalirudin in frozen, premixed, ready-to-use formulation
DEERFIELD, Ill.- Baxter International Inc., a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration approval of Bivalirudin in 0.9 percent Sodium Chloride Injection. "The approval of bivalirudin demonstrates how Baxter brings its innovative technologies together with medicines in ways th
1/22/18 - Bio-Rad Gains Additional U.S. FDA Clearances for Blood Typing Products, Expanding its Offering for the Blood Testing Market
Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, today announced that it has received 510 clearance from the U.S. Food and Drug Administration for the IH- Incubator L and IH- Centrifuge L instruments to be used with the full range of Bio-Rad s IH- System Gel Reagents for manual blood typing m
1/22/18 - Boston Scientific Receives U.S. FDA Approval for Spectra WaveWriter Spinal Cord Stimulator System
By a News Reporter-Staff News Editor at Pharma Business Week Boston Scientific Corporation announced that the U.S. Food and Drug Administration has approved the Spectra WaveWriter? Spinal Cord Stimulator System. It is the first and only system approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy.
1/22/18 - Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Reopening of the Comment Period
SUMMARY: The Food and Drug Administration is reopening the comment period for the document published in the Federal Register on September 26, 2017, announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when
1/22/18 - EC approves Amgen's biosimilar Avastin
Amgen Inc. and Allergan plc said the European Commission approved Mvasi, a biosimilar of Avastin bevacizumab. In September, FDA approved the drug as Mvasi bevacizumab-awwb for all cancer types on Avastin's U.S. label except ovarian cancer. Roche and its Genentech Inc. unit market Avastin.
1/22/18 - Elanco Animal Health Announces U.S. Food and Drug Administration (FDA) Approval of Credelio (lotilaner) to Treat and Protect Against Ticks and Fleas
Today, Elanco Animal Health, a division of Eli Lilly and Company, announced the approval of Credelio . Lotilaner, the active ingredient in Credelio, was selected from hundreds of candidate molecules with this in mind, "said Tony Rumschlag, DVM, Director, Regional Consulting, Elanco Animal Health. Credelio rounds out the Elanco portfolio of comp
1/22/18 - Eli Lilly Animal Health Unit Announces FDA Approval Of Credelio
INDIANAPOLIS- Elanco Animal Health, a division of Eli Lilly and Company, announced the approval of Credelio, a new monthly oral tick and flea treatment for dogs. The new option contains the patented active ingredient lotilaner, which targets the nervous system receptors of ticks and fleas. Credelio will be available in four tablet strengths for dog
1/22/18 - FDA Grants Diazyme 510(k) Clearance to Market Its New EZ Vitamin D Assay for Clinical Chemistry Analyzers
Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration has granted 510 clearance to market its EZ Vitamin D assay for Clinical Chemistry Analyzers. Chong Yuan, Managing Director of Diazyme Laboratories. Diazyme Laboratories, Inc. is an affiliate of General Atomics, headquartered in La Jolla, California.
1/22/18 - GSK receives FDA approval for expanded indication for FLUARIX QUADRIVALENT Influenza Vaccine for persons 6 months and older
By a News Reporter-Staff News Editor at Pharma Business Week GSK announced it has received approval from the US Food and Drug Administration's Center for Biologics Evaluation and Research expanding the indication for FLUARIX QUADRIVALENT to include use in persons 6 months and older. "The flu vaccine is the one vaccine that people of almost al
1/22/18 - Medrobotics Corporation Receives FDA Clearance for World's First and Only Flexible Transabdominal and Transthoracic Robotic Scope
Medrobotics Corp., a medical robotics company, announced today it has received FDA regulatory clearance to market the Flex Robotic System for robot-assisted visualization in general surgical, gynecological and thoracic procedures in the United States. Medrobotics markets the Flex Robotic System, the world s first and only robotic surgical
1/22/18 - Surmodics Receives 510(K) Clearance for Telemark? Coronary/Peripheral Support Microcatheter from the U.S. Food and Drug Administration
Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration 510 clearance for its Telemark?. 014 coronary and peripheral support microcatheter. This is another example of our progress and our commitment to developing highl
1/22/18 - Xcision Receives FDA 510k Clearance for the GammaPod Stereotactic Radiotherapy System for Breast Cancer
By a News Reporter-Staff News Editor at Pharma Business Week Xcision Medical Systems, LLC has announced that the GammaPod Stereotactic Radiotherapy System, the world's first noninvasive external beam system optimized for partial breast treatments, has received 510 clearance from the US Food and Drug Administration. Xcision Founder and CEO Cedric
1/20/18 - Avera To Enroll First Patients in Landmark Lung Cancer Tri-Therapy Clinical Trial [Sudan Tribune]
This clinical trial that received the approval of the FDA is Averas latest collaboration as part its membership in the Worldwide Innovative Networking Consortium. This latest step in our collaboration with WIN represents one clinical trial but is part of our larger goal to revolutionize cancer care through personalized medicine, said Benjamin Solom
1/19/18 - AstraZeneca Announces Approval Of Fasenra In Japan
LONDON- AstraZeneca and MedImmune announced the Japanese Ministry of Health, Labour and Welfare has approved Fasenra as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite treatment with high-dose inhaled corticosteroid and other asthma controllers. The Japanese approval follows US FDA...
1/19/18 - Avera To Enroll First Patients in Landmark Lung Cancer Tri-Therapy Clinical Trial
This clinical trial that received the approval of the FDA is Avera s latest collaboration as part its membership in the Worldwide Innovative Networking Consortium. Through the WIN Consortium, an Avera research team under Solomon s leadership has helped design and implement the clinical trial from the ground up. This breakthrough research i
1/19/18 - Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
SUMMARY: The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503 B of the Federal Food, Drug, and Cosmetic Act." For a drug product compounded by an outsourcing facility to qualify for the exemptions under se
1/19/18 - EC approves Amgen's biosimilar Avastin
Amgen Inc. and Allergan plc said the European Commission approved Mvasi, a biosimilar of Avastin bevacizumab. In September, FDA approved the drug as Mvasi bevacizumab-awwb for all cancer types on Avastin's U.S. label except ovarian cancer. Roche and its Genentech Inc. unit market Avastin.
1/19/18 - Lupin launches generic Vibra-Tabs tablet in US [India Infoline News Service]
Pharma Major Lupin announced the launch of its Doxycycline Hyclate Tablet USP, 100 mg having received an approval from the United States Food and Drug Administration earlier. The stock is currently trading at Rs919, up by Rs0.6 or 0.07% from its previous closing of Rs918.4 on the BSE. The scrip opened at Rs920.25 and has touched a high and low of R
1/19/18 - Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry; Availability
This final guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application. It also describes the conditions under which FDA
1/19/18 - New Drug Delivery Systems Study Results Reported from Huazhong University of Science and Technology (Recent Advances in the Application of Vitamin E...
New Drug Delivery Systems Study Results Reported from Huazhong University of Science and Technology. According to news reporting from Wuhan, People's Republic of China, by NewsRx journalists, research stated, "D-?-tocopheryl polyethylene glycol succinate has been approved by FDA as a safe adjuvant and widely used in drug delivery systems.
1/19/18 - Unknown BTCY May Have Big Upside Ahead of Likely Near-Term FDA Approval
-Biotricity just received FDA clearance for a new cardiomonitoring device and will be launching the product this year into a multi-billion dollar market with just a few competitors. Despite the allure of investing in the next big drug-and seeing 500% stock returns like Sangamo Therapeutics in the last year-looking for alpha generation in other heal
1/18/18 - Bausch + Lomb Receives FDA Approval of Lumify - The Only Over-The-Counter (OTC) Eye Drop With Low-Dose Brimonidine for the Treatment of Ocular Redness
Bausch+ Lomb, a leading global eye health company, announced that the U.S. Food and Drug Administration has approved LUMIFY (TM) as the first and only over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness. "We are proud to offer this unique new OTC eye drop to help our physicians and their patie
1/18/18 - Bausch + Lomb Receives FDA Approval of LUMIFY - The Only Over-The-Counter Eye Drop with Low-Dose Brimonidine for the Treatment of Ocular Redness
BRIDGEWATER, New Jersey- Bausch+ Lomb, a leading global eye health company, announced that the U.S. Food and Drug Administration has approved LUMIFY as the first and only over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness. 'We are proud to offer this unique new OTC eye drop to help our physici
1/18/18 - QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Lung Cancer
GERMANTOWN, Maryland and HILDEN, Germany, January 18, 2018/ PRNewswire/. QIAGEN N.V. today announced that the U.S. Food and Drug Administration has approved a PMA supplement extending the indications for use of QIAGEN's therascreen EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer Ingelheim's targeted therapy GILOTRIF
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