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 The leading web portal for pharmacy resources, news, education and careers October 20, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - October 20, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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10/17/14 - FDA Approves Labeling With Abuse-Deterrent Features For Third Extended-Release Opioid Analgesic
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today approved new labeling for Embeda extended-release capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which altern
10/17/14 - New Multiple Sclerosis Data Have Been Reported by Researchers at Brigham and Women's Hospital (Eosinophilic Fasciitis-like Disorder Developing in the...
New Multiple Sclerosis Data Have Been Reported by Researchers at Brigham and Women's Hospital. According to news reporting originating from Boston, Massachusetts, by NewsRx correspondents, research stated, "Importance: Dimethyl fumarate received FDA approval in March 2013 for treatment of multiple sclerosis and has had a rapid uptake in the field d
10/17/14 - Pfizer Announces FDA Approval Of Abuse Deterrent Labeling For Embeda
NEW YORK CITY- Drugmaker Pfizer Inc. said Friday that the United States Food and Drug Administration has approved an updated label for Embeda extended-release capsules, for oral use, CII, to include abuse-deterrence studies. The updated label states that Embeda has properties that are expected to reduce abuse via the oral and intranasal routes when
10/17/14 - Siemens Announces FDA Clearance of ACUSON SC2000 Prime Ultrasound System
ENP Newswire- 17 October 2014. Release date- 16102014- Siemens Healthcare has announced that the Food and Drug Administration has cleared the new Prime edition of its ACUSON SC2000 premium cardiovascular imaging system- a pioneering system that offers live full-volume color Doppler imaging of heart valve anatomy and blood flow using a new true volu
10/17/14 - United States : FDA approves Esbriet to treat idiopathic pulmonary fibrosis [TendersInfo (India)]
The U.S. Food and Drug Administration today approved Esbriet for the treatment of idiopathic pulmonary fibrosis. Esbriet provides a new treatment option for patients with idiopathic pulmonary fibrosis, a serious, chronic lung disease, said Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA s Center for Drug
10/17/14 - United States : FDA approves Ofev to treat idiopathic pulmonary fibrosis [TendersInfo (India)]
The U.S. Food and Drug Administration today approved Ofev for the treatment of idiopathic pulmonary fibrosis. Today s Ofev approval expands the available treatment options for patients with idiopathic pulmonary fibrosis, a serious, chronic condition, said Mary H. Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA s Center f
10/17/14 - United States : Federal judge approves FDA consent decree with Ascend Laboratories [TendersInfo (India)]
Marshals in May 2014, which the company is then responsible for destroying under the FDA s supervision. In addition, the consent decree prohibits Ascend Laboratories and all other associated persons who act in concert with the company from manufacturing and distributing unapproved drugs until the company obtains FDA approval, including: Pramoxine-H
10/17/14 - UPDATE: FDA Has Approved New Labeling on Pfizer's Embeda
FDA approves labeling with abuse-deterrent features for third extended-release opioid. The U.S. Food and Drug Administration today approved new labeling for Embeda extended-release capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are.
10/16/14 - AnthroTronix Receives FDA Clearance for Brain Health Assessment Tool
AnthroTronix, a research and development company that designs health technology, announced today it has received U.S. Food and Drug Administration clearance for its computerized cognitive test battery known as DANA?. We are pleased that DANA? has sought and received FDA clearance, leading the way for this type of game-changing technology,
10/16/14 - CAGW Releases Poll Results Regarding Use of Biosimilar Drugs
A legal framework to approve biosimilars was established in Europe in 2003, and they have been used safely since the first medication was approved in 2006. However, four years after the passage of PPACA, not a single biosimilar has been approved by the FDA. CAGW's poll shows that 78 percent of voters agree that healthcare costs are out of control a
10/16/14 - CORRECTION - Two FDA Approvals on Same Day Renew Hope for Pulmonary Fibrosis Community
In its press release dated October 16, 2014 at 10:46 AM EST with the headline "Two FDA Approvals on Same Day Renew Hope for Pulmonary Fibrosis Community", the CPF incorrectly spelled a newly FDA approved drug's name. Expected to come separately by the end of November, the surprise FDA decisions on both drugs came on Wednesday. The FDA approved In
10/16/14 - Esbriet Receives FDA Approval Under 'Breakthrough Status'; Diplomat To Distribute
Manufactured by InterMune Inc., Esbriet is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that plays a key role in fibrosis, or scarring, in the lungs. Esbriet was approved by the FDA under the breakthrough therapy designation as a drug that addresses a serious or life-threatening condition and fo
10/16/14 - Esbriet (pirfenidone) receives FDA approval under 'breakthrough status'; Diplomat to distribute
Manufactured by InterMune Inc., Esbriet is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that plays a key role in fibrosis, or scarring, in the lungs. Esbriet was approved by the FDA under the breakthrough therapy designation as a drug that addresses a serious or life-threatening condition and fo
10/16/14 - FDA Approves the Lutonix 035 Drug Coated Balloon [Health & Beauty Close - Up]
C. R. Bard reported that the U.S. Food and Drug Administration has granted approval of the Lutonix 035 Drug Coated Balloon Catheter for percutaneous transluminal angioplasty, after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries wit
10/16/14 - FDA Okays Esbriet To Treat Idiopathic Pulmonary Fibrosis
SOUTH SAN FRANCISCO- Genentech, a part of the Roche Group, said Wednesday the U.S. Food and Drug Administration approved Esbriet as a treatment for idiopathic pulmonary fibrosis in the U.S. The company expects to make Esbriet available to patients within two weeks. According to Genentech, the approval of Esbriet would not have been possible without
10/16/14 - FDA OKs Gilead's Harvoni (Ledipasvir/Sofosbuvir) [Health & Beauty Close - Up]
Gilead Sciences said that the U.S. Food and Drug Administration has approved Harvoni, a once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead Sciences reported in a release that Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approv
10/16/14 - Pulsaderm Rolls Out FDA-Cleared Class II Medical Device LED Red [Professional Services Close - Up]
Pulsaderm recently launched the Pulsaderm Buddy sonic face brush and the FDA- cleared Pulsaderm LED Blue light therapy device, is bolstering its skincare line with the announcement of the FDA- Cleared Class II Medical Device, Pulsaderm LED Red. "Coming off the heels of the successful debut of Pulsaderm's LED Blue, we're thrilled to complement our
10/16/14 - Roche 9-month Currency Neutral Sales Rise, Says FDA Approves Esbriet
SOUTH SAN FRANCISCO- Swiss pharmaceutical giant Roche Holding AG Thursday said sales for the first nine months of the year edged down from the prior-year period, as several currencies remained weaker against the Swiss franc throughout the year, most notably the US dollar. Diagnostics sales were up 6 percent at 7.792 billion francs, amid continued s
10/16/14 - Two FDA Approvals on Same Day Renew Hope for Pulmonary Fibrosis Community
Expected to come separately by the end of November, the surprise FDA decisions on both drugs came on Wednesday. The FDA approved InterMune's Esbrriet and Boehringer Ingelheim's Ofev for IPF. TV, Film and Broadway actress Barbara Barrie, who disclosed recently she has been diagnosed with IPF, is working with non-profit foundation, the Coalition for
10/15/14 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Animal Drug User Fee Cover Sheet
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Animal Drug User Fee Cover Sheet" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville
10/15/14 - CPF Applauds Two FDA Approvals Announced Today for First Drugs for Idiopathic Pulmonary Fibrosis
The Coalition for Pulmonary Fibrosis applauds the two U.S. Food and Drug Administration approvals announced today for Idiopathic Pulmonary Fibrosis, the first drugs approved for the disease in the United States. The CPF, representing tens of thousands of Idiopathic Pulmonary Fibrosis patients is sharing the news with the patient and research comm
10/15/14 - FDA Approves Boehringer Ingelheim's OFEV (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved OFEV capsules for oral use for the treatment of idiopathic pulmonary fibrosis. Granted Breakthrough Therapy designation during its review by the FDA, OFEV, capsules for oral use, taken twice daily, is the only kinase inhibitor approve
10/15/14 - FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. "Esbriet provides a new treatment option for patients with idiopathic pulmonary fibrosis, a serious, chronic lung disease," said Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for
10/15/14 - FDA Approves Esbriet (pirfenidone) for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) in the United States
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has approved Esbriet as a treatment for idiopathic pulmonary fibrosis in the United States. This is a historic day for the people and their families in the United States who live with this deadly, incurable disease, said Sandra Horning, M.D.,
10/15/14 - FDA Approves Expanded Use of Navidea's Lymphoseek for Lymphatic Mapping in Solid Tumors
Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that the U.S. Food and Drug Administration has approved the Supplemental New Drug Application for the expanded use of Lymphoseek injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node...
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