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 The leading web portal for pharmacy resources, news, education and careers February 28, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 28, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 48     Next >>     Go To Page:

2/27/15 - Actavis: FDA OKs LILETTA To Prevent Pregnancy For Up To 3 Years
WASHINGTON- Actavis plc, a global specialty pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, today announced the approval of LILETTA by the U.S. Food and Drug Administration or FDA for use by women to prevent pregnancy for up to three years. Actavis and Medicines360's groundbreaking partnership would allo
2/27/15 - Archroma receives FDA approval for Cartaguard KST additive [EMBIN (Emerging Markets Business Information News]
Switzerland- based color and specialty chemicals company Archroma has received FDA approval for the use of its new Cartaguard KST additive in the manufacture of paper and board for food packaging. The product has been approved by the US Federal Food and Drug Administration under 21 CFR 176.170 and can be used as a grease resistance treatment before
2/27/15 - FDA Approves Allergan's NATRELLE INSPIRA? Round Gel-FilledBreast Implants
Allergan, Inc. today announced that the company has received approval from the U.S. Food and Drug Administration to market NATRELLE INSPIRA? round gel-filled smooth breast implants. The FDA approval of NATRELLE INSPIRA? round gel-filled implants exemplifies our commitment to scientific innovation and to meeting the dynamic needs of plastic s
2/27/15 - FDA Okays Allergan's Natrelle Inspira Round Gel-Filled Breast Implants
WASHINGTON- Allergan Inc. announced that it has received approval from the U.S. Food and Drug Administration or FDA to market Natrelle Inspira round gel-filled smooth breast implants. The FDA approval of Natrelle Inspira round gel-filled smooth breast implants marks the most recent addition to the broad portfolio of currently available Natrelle...
2/27/15 - Immunovaccine Inc. (TSX: IMV) receives Fast Track and Phase I trial approval for Ebola and Anthrax vaccine programs, signs co-development agreement with Gilead Sciences
Immunovaccine Inc., a clinical stage vaccine and immunotherapy company, today announced that the U.S. Food and Drug Administration has approved its application for Fast Track designation and Phase I clinical trials of the DPX-Anthrax and DPX-Ebola vaccines, in conjunction with the mutual co-development agreement signed with Gilead Life Sciences.
2/27/15 - KERYX BIOPHARMACEUTICALS INC - 10-K - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Our first product, AuryxiaTM, an oral, absorbable iron-based compound, received marketing approval from the U.S. Food and Drug Administration, or FDA, in September 2014 for the control of serum phosphorus leve
2/27/15 - LENVIMA? (lenvatinib) Now Available Through Two Specialty Pharmacies, Accredo and Biologics, Inc.
Priority Review is designated for drugs that the FDA believes have the potential to provide a significant improvement of a serious condition. "Eisai is dedicated to innovative science and patient care," said David Trexler, Senior Vice President, Eisai Oncology Business Unit, Eisai Inc. "We are pleased to introduce LENVIMA, a new treatment option t
2/27/15 - McAuliffe signs bill on marijuana oil for epilepsy treatment [The Virginian-Pilot]
Terry McAuliffe signed off on bills Thursday allowing people with severe epilepsy to use marijuana oils to treat seizures. The legislation came as welcome relief to Virginia Beach mom Tracie Thomas, whose son Caleb, 12, is in a clinical trial for just such a product. Paul Lyons, a Winchester neurologist, received clearance from the Food and Drug Ad
2/27/15 - New Drug Receives FDA Approval as Orphan Drug for the Treatment of Mesothelioma
According to a Feb. 12, 2015 news release by Verastem, Inc., defactinib, a drug used to treat cancer by killing cancer stem cells, has received orphan drug designation from the U.S. Food and Drug Administration for use in the treatment of mesothelioma. "We are really excited about the FDA's decision," said Melinda Helbock, Founder of The Law Offic
2/27/15 - New Drug Receives FDA Approval as Orphan Drug for the Treatment of Mesothelioma [National Iraqi News Agency (Iraq)]
-According to a Feb. 12, 2015 news release by Verastem, Inc., defactinib, a drug used to treat cancer by killing cancer stem cells, has received orphan drug designation from the U.S. Food and Drug Administration for use in the treatment of mesothelioma. We are really excited about the FDA's decision, said Melinda Helbock, Founder of The Law O
2/26/15 - Actavis : FDA Approves New Antibacterial Drug Avycaz
WASHINGTON- Actavis plc announced the U.S. Food and Drug Administration has approved AVYCAZ. AVYCAZ is part of Actavis' leading portfolio of infectious disease products that address some of the most dangerous pathogens. AVYCAZ was granted priority review and approval as a Qualified Infectious Disease Product in accordance with the Generating Antibi
2/26/15 - FDA Approves Expansion of Pivotal Scleroderma STAR Trial to 20 Clinical Sites
Cytori Therapeutics, Inc. announced today that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. Steven Kesten, Chief Medical Officer of Cytori Therapeutics. There are only about 35 specialized scleroderma centers in the U.S. and this decision to expand the trial si
2/26/15 - GLENMARK GETS USFDA NOD FOR CONTRACEPTIVE GENERIC
Glenmark Pharmaceuticals has received approval from the United States Food and Drug Administration for generic Ashiyna contraceptive tablets. It has launched these tablets in the United States market. Glenmark Generics Inc, USA, a subsidiary of Glenmark, has introduced Ashiyna extended-cycle oral contraceptive tablets, which are equivalent of Teva.
2/26/15 - Ireland,United States : FDA Approves the VenaSeal(TM) Closure System for Treatment of Clinically Symptomatic Venous Reflux [TendersInfo (India)]
Medtronic plc today announced U.S. Food and Drug Administration approval for VenaSeal (TM) closure system, a minimally invasive procedure that uses a specially formulated medical adhesive to close lower superficial extremities such as the great saphenous vein in patients with symptomatic venous reflux. Venous reflux disease, also known as chronic..
2/26/15 - Sanofi Gets FDA Approval Of Once-Daily Basal Insulin Toujeo
PARIS- Sanofi announced that the U.S. Food and Drug Administration or FDA) approved Toujeo (insulin glargine injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, wh
2/26/15 - Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo
Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo Paris, France- February 26, 2015- Sanofi announced today that the U.S. Toujeo is expected to be available in the U.S. at the beginning of Q2 2015. " Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which has supported patients in the managemen
2/26/15 - Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo
PARIS, Feb. 25, 2015/ PRNewswire-USNewswire/ Sanofi announced today that the U.S. Food and Drug Administration approved Toujeo , a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. "Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which
2/26/15 - The Leukemia & Lymphoma Society Applauds Therapy Advances for Myeloma Patients
The FDA recently expanded the existing indication for Celgene's lenalidomide in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. The drug was approved through the FDA priority review process which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may prov
2/25/15 - Actavis Receives U.S. FDA Approval for AVYCAZ? (CEFTAZIDIME-AVIBACTAM)
AVYCAZ is part of Actavis' leading portfolio of infectious disease products that address some of the most dangerous pathogens. "The FDA approval of AVYCAZ is an important step forward in enhancing our ability to respond to serious infections caused by difficult to treat Gram-negative pathogens," said David Nicholson, Executive Vice President, Glob
2/25/15 - Agendia Receives New FDA Clearance for MammaPrint FFPE Breast Cancer Test
By a News Reporter-Staff News Editor at Biotech Week Agendia, a leading molecular diagnostics company that develops and markets genomic diagnostic products, announced that it has received 510 clearance from the U.S. Food and Drug Administration for the company's MammaPrint breast cancer recurrence test in FFPE tissue. The MammaPrint FFPE test
2/25/15 - Diplomat to Dispense Novartis Myeloma Drug FARYDAK
Diplomat Pharmacy, Inc. announced today that the U.S. Food and Drug Administration has approved FARYDAK for the treatment of patients with multiple myeloma. According to the National Cancer Institute, each year about 21,700 Americans are diagnosed with multiple myeloma and 10,710 die from the disease. "FARYDAK offers a focused treatment to
2/25/15 - FDA approves new antibiotic combo from Actavis
The drug from Actavis PLC contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria. The Food and Drug Administration approved Avycaz to treat certain abdominal infections, in combination with another drug, and for complicated urinary-tract infections, including kidney infections, for which there ar
2/25/15 - FDA Approves the Medtronic's VenaSeal Closure System; Cytori Receives Positive European Opinion on Orphan Drug Status
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 24, 2015.{ nfg} Medtronic plc announced U.S. Food and Drug Administration approval for VenaSeal (TM) closure system, a minimally invasive procedure that uses a specially formulated medical adhesive to close lower superficial extremities such a
2/25/15 - MEDTRONIC -FDA Approves the VenaSeal Closure System for Treatment of Clinically Symptomatic Venous Reflux
Release date- 24022015- DUBLIN Medtronic plc today announced U.S. Food and Drug Administration approval for VenaSeal closure system, a minimally invasive procedure that uses a specially formulated medical adhesive to close lower superficial extremities such as the great saphenous vein in patients with symptomatic venous reflux. Nick Morrison, nat
2/25/15 - MerLion announces FDA approval of finafloxacin otic suspension
By a News Reporter-Staff News Editor at Biotech Week MerLion Pharmaceuticals, a biopharmaceutical company headquartered in Singapore with clinical development operations in Berlin, Germany, announced that an otic suspension of finafloxacin has been approved by the FDA to treat acute otitis externa, commonly known as "swimmer's ear", caused by Pse
Articles(s): 1 - 25 of 48     Next >>     Go To Page:


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