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 The leading web portal for pharmacy resources, news, education and careers April 19, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - April 19, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 64     Next >>     Go To Page:

4/18/14 - Boston Scientific Receives FDA Approval of New Defibrillators and Heart Failure Devices [Professional Services Close - Up]
Boston Scientific Corp. has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. These newly approved devices continue the Boston Scientific history of projected longevity and a six-year CRT-D warranty. Extending the Boston Scientific portfolio of defibrillators, the ICDs in t
4/18/14 - Carestream's New Bone Suppression Software Receives FDA Clearance, Now Available Worldwide
By a News Reporter-Staff News Editor at Health& Medicine Week "Our new software collects radiation dose details from our CR and DR systems and sends this data to PACS systems that support the IHE dose monitoring profile," said Helen Titus, Carestream's Marketing Director of X-ray Solutions. "We are one of the first companies to provide radiation
4/18/14 - FDA approves Ragwitek for short ragweed pollen allergies
Release date- 17042014- The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue to treat short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 years through 65 years of age. 'The approval of Ragwitek offers millions of adults living with ragweed p
4/18/14 - Lannett Gets FDA Approval for Diazepam Oral Solution (Concentrate), 5 mg/mL [Health & Beauty Close - Up]
Lannett Company, Inc. said that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Diazepam Oral Solution, 5 mg/ mL, a Schedule C-IV controlled drug. "We believe our ANDA for Diazepam Oral Solution, 5 mg/mL was the first bioequivalent Diazepam Oral Solution product approved by the FDA,"
4/18/14 - Reverse Medical Corp. Gets FDA IDE Approval for BARREL Vascular Reconstruction Device [Health & Beauty Close - Up]
Reverse Medical Corp. has announced FDA IDE approval for clinical investigation of their BARREL Vascular Reconstruction Device. "FDA approval of this clinical trial represents a significant accomplishment, and we're excited to begin evaluating this promising endovascular treatment alternative for patients with limited options available today.
4/18/14 - United States : FDA approves Ragwitek for short ragweed pollen allergies [TendersInfo (India)]
The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue to treat short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 years through 65 years of age. The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the Un
4/17/14 - ALK announces FDA approval for Merck's ragweed sublingual allergy immunotherapy tablet RAGWITEK(r)
Licensed to Merck for North America by ALK, RAGWITEK (r) is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Jens Bager, ALK's President and
4/17/14 - ALK announces FDA approval for Merck's ragweed sublingual allergy immunotherapy tablet RAGWITEK
Licensed to Merck for North America by ALK, RAGWITEK is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Jens Bager, ALK s President a
4/17/14 - Breathe Technologies, Inc. Announces FDA Clearance For NIOV System For Use With Compressed Gas
The previous four FDA clearances cover the use of the Breathe NIOV System with compressed oxygen for home and institutional use, and include invasive and noninvasive patient circuits. The Breathe NIOV System is the first and only FDA- cleared, wearable, ventilation system for people with respiratory insufficiency. The new FDA clearance for use of t
4/17/14 - FDA Approves Merck's RAGWITEK? (Short Ragweed Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Short Ragweed Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Adults
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved RAGWITEK? Tablet for Sublingual Use. David Skoner, director, Division of Allergy and Immunology, Allegheny Health Network, and a clinical investigator in Merck's sublingual allergen immunotherapy tablet program.
4/17/14 - FDA Approves Ragwitek for Short Ragweed Pollen Allergies
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. "The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease," said Karen Midthun, M.D., director of the FDA's Center for Bi
4/17/14 - FDA Grants Approval to Merck's Grastek (Timothy Grass Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Grass Pollen-Induced... [Health & Beauty Close - Up]
FDA Grants Approval to Merck's Grastek Sublingual Tablet as Immunotherapy to Treat Grass Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Children and Adults. Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved Grastek Tablet for Sublingual Use.
4/17/14 - GSK and Genmab Receive FDA Approval for Arzerra (ofatumumab) as First-Line Treatment in Combination with Chlorambucil for Patients with Chronic Lymphocytic Leukemia (CLL) for Whom Fludarabine-Based Therapy is Considered Inappropriate
Company Announcement Arzerra now approved for use in previously untreated patients for whom fludarabine-based therapy is considered inappropriate Approval based on Phase III data from study with ofatumumab+ chlorambucil Copenhagen, Denmark; April 17, 2014- GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administra
4/17/14 - QMED -Boston Scientific Wins FDA Approval of Mini ICDs
Release date- 16042014- In but another sign of miniaturization in the cardiovascular space, Boston Scientific Corp. has announced FDA approval of defibrillators that it says are 20% smaller by volume and 24% thinner than competitive devices. The FDA approval involved the Dynagen Mini and Inogen Mini ICDs from Boston Scientific. Boston Scientific CE
4/17/14 - Teva Settles Patent Litigation with Pfizer on Celebrex
Under the terms of the settlement, Teva may launch its generic versions in December, 2014, or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Headquartered in Israel, Teva is the
4/16/14 - Boehringer Ingelheim pleased with 2013 financial year [Global Data Point]
This resulted in a 2.4 percentage point improvement in the return on net sales to 15 per cent. For the last mentioned indication, the company received marketing approval from the US Food and Drug Administration for PRADAXA at the beginning of April. "We can say that Boehringer Ingelheim came through 2013 well, despite extraordinary effects and
4/16/14 - Boston Scientific Announces FDA Approval Of Innovative New Defibrillators And Heart Failure Devices [Global Data Point]
These newly approved devices continue the Boston Scientific history of industry-leading projected longevity and a six-year CRT-D warranty.&# x0D;. Extending the Boston Scientific portfolio of defibrillators, the ICDs in the MINI family are the world's smallest and thinnest devices and are designed for patient comfort. "With these new devices and o
4/16/14 - Boston Scientific Reports FDA Approval for Heart Failure Devices; Teva Unveils Generic Lunesta Tablets in US
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 15, 2014.{ nfg} Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. These newly approved devices continue the Boston Scientific history of
4/16/14 - FDA Approves Biogen Idec's ALPROLIX?, the First Hemophilia B Therapy to Reduce Bleeding Episodes with Prophylactic Infusions Starting at Least a Week...
By a News Reporter-Staff News Editor at Biotech Week "The FDA approval of ALPROLIX is a significant milestone for the hemophilia B community, and represents an important first step in our commitment to transform the care of people with hemophilia," said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. The National Hemophilia Foun
4/16/14 - FDA approves Tanzeum to treat type 2 diabetes
Release date- 15042014- The U.S. Food and Drug Administration today approved Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States.
4/16/14 - FDA approves Tanzeum to treat type 2 diabetes [Emirates News Agency (WAM) (United Arab Emirates)]
Washington, 15th Apr. 2014- The U.S. Food and Drug Administration today approved Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage
4/16/14 - GREER Laboratories, Inc. Announces FDA Approval of ORALAIR, the First Sublingual Allergy Immunotherapy Tablet, for the Treatment of Grass Pollen...
By a News Reporter-Staff News Editor at Biotech Week GREER Laboratories, Inc., a leading developer and provider of allergy immunotherapy products and services, announced that the U.S. Food and Drug Administration has approved ORALAIR sublingual allergy immunotherapy tablet. Allergy immunotherapy in the United States has traditionally been..
4/16/14 - GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum (albiglutide)
Release date- 15042014- GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved TanzeumTM for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. The FDA approval of albiglutide is based on the results of GSK's comprehensive Phase III Harmony programme, consisting of eight trials and in
4/16/14 - Investigational New Drug Application Cleared by FDA for OMS721 in Thrombotic Microangiopathies
By a News Reporter-Staff News Editor at Biotech Week Omeros Corporation announced that its Investigational New Drug Application to evaluate OMS721 for the inhibition of complement? Omeros announced last year that the FDA granted OMS721 Orphan Drug designation for the inhibition of complement? FDA's clearance of the IND allows the initiation of th
4/16/14 - KRS Global Biotechnology, Inc. Announces FDA Approval of Becoming a Registered Outsourcing Facility (via section 503B); Compounding Quality Act
KRS Global Biotechnology, Inc. is pleased to announce that it has been recognized as a registered 503 B Large-scale sterile compounding "Outsourcing Facility" by the Food& Drug Administration under the Drug Quality& Security Act. About FDA's Implementation of the Compounding Quality Act. About KRS Global Biotechnology, Inc..
Articles(s): 1 - 25 of 64     Next >>     Go To Page:


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