Latest News - FDA Approval/Clearance

Thursday, February 15, 2018

Food and Drug Administration Makes Statement on Advancing Development of Novel Treatments for Neurologic Conditions as Part of an Effort to Modernize Drug Review Programs

Scott Gottlieb MD, Commissioner with the Food and Drug Administration (FDA) announced several new FDA guidelines for the development of drugs to treat neurologic diseases, noting that progress across …

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Wednesday, February 14, 2018

Food and Drug Administration Permits Marketing of First Blood Test to Evaluate Concussion

As part of the breakthrough devices program, the Food and Drug Administration (FDA) permitted marketing of the brain trauma indicator (Banyan Biomarkers, Inc; San Diego, California), the first blood t…

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Wednesday, February 14, 2018

New Dose of Generic Glatiramer Acetate Injection for Treatment of Relapsing Multiple Sclerosis Approved by Food and Drug Administration

Sandoz announced that the Food and Drug Administraion (FDA) had approved a generic form of glatiramer acetate (Glatopa,Sandoz) in injectable form at a dose of 40 mg/mL 3 times per week for relapsing f…

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Tuesday, February 06, 2018

Food and Drug Administration Grants Breakthrough Therapy Designation for ZX008 for Treatment of Dravet Syndrome

Low-dose fenfluramine (ZX008, Zogenix) is classified as an orphan drug for the treatment of two rare forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome. Positive results from the first piv…

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Tuesday, January 16, 2018

The Food and Drug Administration Mini-Sentinal Shows Rivaroxaban Is Associated with a Lower Risk of Ischemic Stroke Vs. Warfarin

Rivaroxaban (Janssen Pharmaceuticals) is an antithrombotic medication that inhibits clotting Factor Xa. It is available in oral tablet formulation for patients at risk of, or being treated for, deep v…

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Tuesday, January 09, 2018

Sublingual Formulation of Riluzole Bioequivalent to Tablet Formulation

Biohaven announced positive results from its bioequivalence study of BHV-0223, an innovative sublingual formulation of riluzole, currently available as a 50-mg tablet, which is currently the standard-…

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Tuesday, November 07, 2017

Oral Vimpat Approved for Use in Pediatric Patients with Partial-Onset Seizures

The FDA approved a label extension for Vimpat (lacosamide, UCB) CV as an oral option for the treatment of partial-onset seizures (POS) in pediatric patients four years and older. The expanded ind…

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Tuesday, October 24, 2017

FDA Fast-Tracks Alzheon’s Anti-Amyloid Alzheimer’s Agent

The FDA has granted Fast Track designation to Alzheon, Inc.’s investigational anti-amyloid drug ALZ-801 for the treatment of Alzheimer’s disease (AD). Using a precision medicine approach, …

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Thursday, October 12, 2017

Once-Daily Lyrica Formulation Wins FDA Approval

The FDA has approved Lyrica CR (pregabalin, Pfizer) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and t…

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Monday, October 09, 2017

Next-Generation VNS System and Implantable Device Approved

LivaNova has received FDA approval for its next-generation Vagus Nerve Stimulation (VNS) Therapy Programming System for drug-resistant epilepsy. The FDA has also approved the company's SenTiv…

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Wednesday, October 04, 2017

FDA Greenlights Two Generic Glatiramer Acetate Formulations for Relapsing MS

The FDA approved Mylan’s generic versions of glatiramer acetate, including a three-times weekly 40mg/mL formulation of glatiramer acetate and a once-daily 20mg/mL formulation…

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Wednesday, September 20, 2017

FDA Approves Intellis Device for Intractable Pain

The FDA has approved the Intellis platform (Medtronic) for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal c…

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Friday, September 15, 2017

Briviact Approved as Monotherapy for Partial-Onset Seizures

The FDA has approved a supplemental new drug application for Briviact (brivaracetam, UCB) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epile…

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Thursday, September 14, 2017

Aptiom Approved for Partial-Onset Seizures in Patients Four Years of Age and Older

The FDA has approved the supplemental New Drug Application (sNDA) to expand the indication for Aptiom (eslicarbazepine acetate, Sunovion) to include treatment of partial-onset seizures in childre…

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Thursday, August 31, 2017

Austedo Approved for Treatment of Tardive Dyskinesia

The FDA has approved Austedo (deutetrabenazine, Teva Pharmaceutical Industries Ltd.) tablets for the treatment of tardive dyskinesia in adults. The approval was based on results from two Phase 3 …

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