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 The leading web portal for pharmacy resources, news, education and careers February 25, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 25, 2017

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 118     Next >>     Go To Page:

2/17/17 - Amneal Introduces Alosetron Hydrochloride Tablets, New Generic for Lotronex
By a News Reporter-Staff News Editor at Drug Week- Amneal Pharmaceuticals LLC has launched alosetron hydrochloride tablets, an AB-rated generic equivalent to Lotronex , in 0.5 mg and 1 mg strengths. The Amneal product is one of only two FDA- approved generic-equivalents for Lotronex currently available. Amneal's generic received FDA approval
2/17/17 - FDA approves deflazacort for Duchenne muscular dystrophy but manufacturer delays launch over price concerns [Sudan Tribune]
The first corticosteroid to be made available in the United States to treat Duchenne muscular dystrophy is being priced at US $89,000 a year compared with US $1,000 a year outside the United States, say congressmen. The US Food and Drug Administration has approved the first corticosteroid to be made available in the United States for the treatment
2/17/17 - FDA Approves Expanded Indication for Medtronic Freezor Xtra Cryoablation Catheter
Release date- 16022017- DUBLIN- Medtronic plc today announced the U.S. Food and Drug Administration has approved its Freezor Xtra Cryoablation Catheter for treating patients with atrioventricular nodal re-entrant tachycardia, a life-threatening abnormal heart rhythm. 'Medtronic is pleased with the FDA's decision to approve the expanded use of the..
2/17/17 - FDA Approves Expanded Indication for Medtronic Freezor Xtra Cryoablation Catheter [Sport360]
DUBLIN- Feb. 16, 2017- Medtronic plc today announced the U.S. Food and Drug Administration has approved its Freezor Xtra Cryoablation Catheter for treating patients with atrioventricular nodal re-entrant tachycardia, a life-threatening abnormal heart rhythm. "Medtronic is pleased with the FDA`s decision to approve the expanded use of the FreezorXt
2/17/17 - FDA approves new psoriasis drug that induced suicide in trial
The US Food and Drug Administration (FDA) has approved Valeant's Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or inj
2/17/17 - FDAnews Announces How to Integrate FDA Device Approval and Reimbursement Webinar, Feb. 22, 2017
What are the critical reimbursement questions manufacturers should be asking before selecting an FDA approval pathway? Join Steve Terman Principal Attorney, Olson Frank Weeda Terman Matz and Gordon Schatz President, Schatz Reimbursement Strategies on Feb. 22 when they'll explain how to strategically blend reimbursement with FDA regulatory i
2/17/17 - Myriad's BRACAnalysis CDx Test Successfully Identified Metastatic Breast Cancer Patients with Improved Outcomes from AstraZeneca's PARP Inhibitor, Olaparib
Of the 302 patients in the study, 98 percent tested positive for germline BRCA1/2 mutations as determined by Myriad s FDA- approved BRACAnalysis CDx test. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CD
2/17/17 - Perrigo Announces FDA Final Approval For Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for hydrocodone bitartrate and homatropine methylbromide oral solution, 5 mg/1. 5 mg per 5 mL. Perrigo Company plc, a top five global over-the-counter consumer goods and pharmaceutical company, offers patients and customers high quality p
2/17/17 - Spiriva Respimat Approval Expanded to Treat Pediatric Asthma
The US FDA has expanded the use of Spiriva Respimat for the long-term, once-daily maintenance treatment of asthma for pediatric patients age 6-11, which means the therapy is approved for use in people age 6 and older.
2/17/17 - USFDA APPROVES LUPIN'S ORAL SOLUTION
The US Food and Drug Administration has given approval to Lupin Limited for the generic version of hydrocodone bitartrate and homatropine methylbromide oral solution 5 mg/1. 5 mg per 5 ML.
2/16/17 - Capillus Laser Therapy Caps Receive FDA Clearance For Over-The-Counter Use
Capillus , LLC, a medical device manufacturer focused on providing customers with the best products in treatment for hair loss, announced today that the U.S. Food and Drug Administration has cleared its at-home laser therapy caps for over-the-counter treatment of hair loss, as well as its clinical-use standing laser unit, making it the only such
2/16/17 - FDA Approves Expanded Indication for Medtronic Freezor Xtra Cryoablation Catheter
Medtronic issued the following news release:. Medtronic plc today announced the U.S. Food and Drug Administration has approved its Freezor Xtra Cryoablation Catheter for treating patients with atrioventricular nodal re-entrant tachycardia, a life-threatening abnormal heart rhythm. "Medtronic is pleased with the FDA's decision to approve the expand
2/16/17 - FDA Approves Expanded Indication for Medtronic Freezor Xtra Cryoablation Catheter
Demonstrated Safe and Effective for Treating Patients with Abnormal Heart Rhythm of AVNRT DUBLIN- Feb. 16, 2017- Medtronic plc today announced the U.S. Food and Drug Administration has approved its Freezor Xtra Cryoablation Catheter for treating patients with atrioventricular nodal re-entrant tachycardia, a life-threatening abnormal heart rhythm.
2/16/17 - FDA Expands Approval of SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved SPIRIVA RESPIMAT for the long-term, once-daily maintenance treatment of asthma in people age 6 and older. The FDA approved the Supplemental New Drug Application under a priority review designation, and the FDA also granted pediatric...
2/16/17 - Medigus Receives Approval for Commencement of the First Multi-Center MUSE Clinical Study from CFDA in China
OMER, ISRAEL 02/16/17 Medigus Ltd., a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, today announced that the China Food and Drug Administration, or CFDA, has approved the commencement of the first multi-center MUSE? Clinical Study in China. "With the approval of the
2/16/17 - SILIQ (BRODALUMAB) APPROVED BY US FDA
Through a collaboration agreement, AstraZeneca granted Valeant, an expert in dermatology, the exclusive license to develop and commercialise Siliq globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd through an agreement with Amgen, and in Europe, where LEO Pharma holds exclusive rights to
2/16/17 - Spiriva Respimat Approval Expanded to Treat Pediatric Asthma
The US FDA has expanded the use of Spiriva Respimat for the long-term, once-daily maintenance treatment of asthma for pediatric patients age 6-11, which means the therapy is approved for use in people age 6 and older.
2/16/17 - Valeant Pharma: FDA Approves BLA For Brodalumab Injection
Valeant expects to commence sales and marketing of SILIQ in the U.S. in the second half of 2017.. In August 2015, Valeant entered into a collaboration agreement with AstraZeneca granting Valeant an exclusive license to develop and commercialize SILIQ globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Ki
2/16/17 - Valeant Receives FDA Approval Of SILIQ? (Brodalumab) For Moderate-To-Severe Plaque Psoriasis
Valeant Pharmaceuticals International, Inc. today announced that the U.S. Food and Drug Administration has approved the Biologics License Application for SILIQ? injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis. Valeant expects to commence sales and marke
2/16/17 - Valeant Surrenders Early Gains After SILIQ's FDA Approval
Valeant Pharmaceuticals Intl Inc shares are trading lower by $0.42 at $16.44 in Thursday's session. Before the open, the company announced it received FDA approval for SILIQ. The ensuing decline took Valeant' s well below Wednesday's close, falling all the way to $16.12, but has since rebounded back into the mid- $16 handle.
2/15/17 - Audentes Therapeutics Announces FDA Clearance of Investigational New Drug Application for AT342 to Treat Crigler-Najjar Syndrome
By a News Reporter-Staff News Editor at Biotech Week- Audentes Therapeutics, Inc., a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, announced that the U.S. Food and Drug Administration has cleared the investigational new drug application for A
2/15/17 - Cepheid Announces FDA Clearance Of Xpert Xpress Flu And Xpert Xpress Flu/RSV
Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration to market Xpert Xpress Flu and Xpert Xpress Flu/RSV. The tests are Cepheid's first Xpress branded products all of which are expected to deliver results in 30 minutes or less. 1. "For too long, clinicians have been asked to treat suspected case
2/15/17 - FDA Grants PMA Approval for Hologic's Aptima Hepatitis C Quant Dx Assay
Hologic, Inc. announced today that the United States Food and Drug Administration has granted PMA approval for the Company's hepatitis C virus assay for quantitation of HCV viral load and confirming active HCV infection on the fully automated Panther system. "HCV therapeutic options continue to evolve rapidly with highly effective antiviral..
2/15/17 - The FDA has Approved Tirosint-SOL, Levothyroxine in Liquid Solution for the American Market, IBSA Patent
It is on the list of the World Health Organisation's essential medicines, and is among the most effective, safe, basic and one of the three most widely prescribed medications in the world, as well as the second most prescribed in the United States. The FDA approval of Tirosint-SOL for the US market opens up very interesting opportunities for our co
2/14/17 - Amgen Submits Supplemental Biologics License Application For BLINCYTO (Blinatumomab) In Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
Amgen today announced the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration for BLINCYTO to include overall survival data from the Phase 3 TOWER study, supporting the conversion of BLINCYTO's accelerated approval to full approval. The sBLA also includes new data supporting the treatment of pati
Articles(s): 1 - 25 of 118     Next >>     Go To Page:


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