FDA Approvals & Reviews: TAMIFLU generic, CDRH PMA Summaries – Drug and Device Digest

FDA BRIEF: Week of Aug 1, 2016

FDA approved


TAMIFLU (oseltamivir phosphate) First GENERIC version

Natco Pharma , Pine Brook, NJ, USA

INDICATION:  Treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.


  • Tamiflu approved in 1999
  • First generic approved based on same high-quality and strength as branded Tamiflu




AXIUM Neurostimulator System
Spinal Modulation, Menlo Park, CA, USA
Approval Date: February 26, 2016

Image of Axium Neurostimulator System

INDICATION FOR USE: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II  SUMMARY

BLAZER  Open-Irrigated Ablation Catheter
Boston Scientific Corporation, San Jose, CA, USA
Approval Date: February 24, 2016

Image of Blazer Open-Irrigated Ablation Catheter

INDICATION FOR USE:Hhen used with a Maestro 4000 Radiofrequency (RF) Controller and MetriQ Irrigation Pump, is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and radiofrequency ablation of sustained or recurrent Type 1 Atrial Flutter in patients age 18 or older.  SUMMARY

SORIN PERCEVAL Sutureless Heart Valve
Sorin Group Canada Inc., Bumaby, BC, CANADA 
Approval Date: January 8, 2016

Image of Sorin Perceval Sutureless Heart Valve

INDICATION FOR USE: Bioprosthesis  indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valvesSUMMARY

STORZ Medical Duolith SD1 Shock Wave Therapy Device
Storz Medical AG, Tagerwilen, Switzerland
Approval Date: January 8, 2016

Image of Storz Medical Duolith SD1 Shock Wave Therapy Device

INDICATION FOR USE: Extracorporeal shock wave treatment of heel pain due to chronic proximal plantar fasciitis for patients of age greater than 18 years with a history of failed alternative conservative therapies for at least 6 months. Chronic proximal plantar fasciitis is defined as traction degeneration of the plantar fascial band at the origin on the medial calcaneal tuberosity that has persisted for six months or more. SUMMARY

OMNIGRAFT Dermal Regeneration Matrix
Integra LifeSciences Corporation, Plainsboro, NJ, USA 
Approval Date: January 7, 2016

INDICATION FOR USE: Treatment of partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care. SUMMARY

CLOSER Vascular Sealing System (VSS)
Rex Medical, Conshohocken, PA 
Approval Date: February 12, 2016

Photo of Closer Vascular Sealing System

INDICATION FOR USE: Percutaneous closure of femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing 5, 6, or 7Fr procedural sheaths. SUMMARY

PD-L1 IHC 28-8 pharmDx
Dako North America, Carpinteria, CA, USA
Approval Date: January 22 , 2016

Image of PD-L1 IHC 28-8 pharmDx

INDICATION FOR USE: Qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) melanoma tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity.

PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO ® (nivolumab).

Positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO® SUMMARY

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