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 The leading web portal for pharmacy resources, news, education and careers February 23, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 23, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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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
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 - 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.
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