FDA BRIEF: Week of January 23, 2017

FDA approved


TRULANCE (plecanatide) tablets

Synergy Pharmaceuticals, New York, NY, USA 

Image result for trulance
Source: Google

INDICATION:  Adults for the treatment of chronic idiopathic constipation (CIC).

UNMET NEED:

  • ~ 42 million people affected by constipation
  • CIC causes persistent constipation with no structural or biochemical explanation
  • Need for new therapies for appropriate treatment

REG PATHWAY: NDA

MECHANISM OF ACTION: Plecanatide and active metabolite act locally on luminal surface of intestinal epithelium resulting in increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevation stimulates secretion of chloride and bicarbonate into the intestinal lumen, resulting in increased intestinal fluid and accelerated transit.

EFFICACY:

  • Two 12-week, double-blind, randomized, multicenter clinical studies (n=905, 820), TRULANCE vs. placebo
  • Primary Endpoint: Responder analysis and change-from-baseline in complete spontaneous bowel movements (CSBM) and SBM endpoints
  • Assessed using daily patient input in electronic diary
  • Frequency of CSBMs/week seen as early as week 1; maintained through week 12
  • Also improvements in stool frequency, stool consistency, straining with bowel movements

SAFETY: Most common and serious side effects  was diarrhea

LABEL


 class


VIOGUARD Self-Sanitizing Keyboard 
Vioguard, Kirkland, WA, USA
vio.JPG
Source: Vioguard

INDICATION FOR USE: For use in a healthcare environment to reduce microbial populations typically found on a computer keyboard.

Device Effectiveness: In laboratory testing, the Vioguard Self-Sanitizing Keyboard (Model UVKB50) has been shown to be effective at reducing populations of the following microorganisms when operated at its factory power setting of 240 mW-s/cm2:

Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Klebsiella pneumonia

REG PATHWAY: De Novo Request
  • Regulation Number: 880.6600
  • Regulation Name: Ultraviolet Radiation (UV) Chamber Disinfection Device
  • Regulatory Classification: Class II
  • Product Code: OSZ

GENERIC DEVICE TYPE:

An ultraviolet radiation (UV) chamber disinfection device intended for the low-level surface disinfection of non-porous equipment surfaces by dose-controlled UV irradiation. This classification does not include self-contained open chamber UV disinfection devices intended for whole room disinfection in a healthcare environment.

RISKS AND MITIGATIONS:
  • Inadequate Equipment Disinfection: Performance Testing,  Labeling
  • UV Radiation Exposure: Performance Testing, Labeling
  • Electrical Shock: Electrical Safety Testing
  • Electromagnetic Interference:Electromagnetic Compatibility (EMC) Testing,  Labeling
  • Ozone Exposure: Ozone Generation Limits, Labeling
  • Processed Equipment Incompatibility: Performance Testing, Labeling
  • Contamination of Device: Cleaning and Disinfection Validation, Labeling
  • Software Malfunction: Hazard Analysis, Verification and Validation
  • Special Controls: Performance testing, Software verification, validation, and hazard analysis,  Electrical, Mechanical safety, Electromagnetic Compatibility, Labeling
TEAR DUCT OCCLUDER
Innovatex, Weston, MA, USA
inno
Source: Innovatex
INDICATION FOR USE:  Temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts.
REG PATHWAY: De Novo Request
  • Regulation Number: 21 CFR 886.5838
  • Regulation Name: Nasolacrimal Compression Device
  • Regulatory Classification: Class I Exempt
  • Product Code: PLX

GENERIC DEVICE TYPE:

Nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.

CLASSIFICATION ORDER


 

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