The Form 483 issued to Noven by the FDA carried 13 counts.Noven is the manufacturer of the Daytrana transdermal patch, a product often prescribed to individuals - including children - with attention deficit hyperactivity disorder (ADHD). The Daytrana patch is designed to feed medication in a controlled fashion to the patient through the skin. However, there have been reports of Daytrana skin color loss and other Daytrana side effects associated with the product. While rare, the loss of pigmentation can be permanent. Both the manufacturer and the FDA recommend rotating application sites to avoid impacting the same area of skin and risking skin color loss.
The FDA has warned that such Daytrana skin color loss can be permanent.
According to various reports, the Noven manufacturing facility located in Miami, Florida, was subject to a series of inspections from June 22 through July 10 of this year. Inspectors found various deficiencies. To wit, the accuracy, sensitivity, specificity and reproducibility of test methods were not established and documented. The Form 483 notes that cold flow testing and testing of adhesive transfer were lacking for Noven’s Minivelle, and Daytrana transdermal patches.
When a batch failure has been detected, a manufacturer is required to file an NDA field alert within three working days following notification or discovery that a batch has experienced any kind of failure. The FDA noted that Noven had dropped the ball on this requirement. Written procedures normally produced to ensure that products possess the required identity, strength, quality and purity were lacking.
Any written procedures that did exist were found to lack any requirement for calibration of instruments and apparatus employed in the manufacture of products, at suitable intervals.
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Amongst other issues, the FDA noted that Noven initiated a nationwide recall, on July 27, of no fewer than 125,250 Daytrana skin patches due to an adhesive peel force that was out of specification.
Yet another area of concern that may be of interest to any Daytrana lawyer currently handling a case was the finding that an in-house analyst at Noven’s Miami plant, who remained the lone individual undertaking cold flow testing for a two-year period, was inadequately trained.
Are such lapses contributing to Daytrana skin color loss? Any Daytrana attorney handling a Daytrana lawsuit will most certainly be asking that question.
READER COMMENTS
patti kelly
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Michelle Fitzgerald
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Sherry Medellin
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Christy Maddux
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Kim
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Leslie
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Amanda Treece
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So, PLEASE! PLEASE! PLEASE!!! For the sake of all individuals who take DAYTRANA and it makes their lives manageable, consider this: DAYTRANA enables individuals to be functioning members of society; to be able to learn and experience academic successes; to be able to grow and mature emotionally; to be able to participate in and achieve successes in everyday life; to "fit in" socially and hopefully, not be made fun of for being different or behaving differently (at least no more so than the usual that occurs in schools); and allows the individual(s) and their family members some piece of mind knowing that their disability is being managed and under control better than it has ever been before. Please get the DAYTRANA patches back into continuous production as soon as humanly possible! NO MORE OF THIS START AND STOP PRODUCTION! Do whatever you need to do to get the FDA off your backs snd out of your facility! Follow the law and the required/defined guidelines you know you are supposed to follow as drug manufacturers. The FDA will inspect your facility and you know it. Stop trying to circumvent the process for profits! Look at the profits you have cost your company, your
shareholders, your employees, your CHOICE, etc. and at what expense??!? The health and well-being of millions of children and adults with a disability that greatly affects their quality of life! Isn't that the main purpose for the creation of the drug anyway? SURE IT IS! ???? Millions of children and adults are desperately waiting on Noven Pharmaceuticals to do what is the right thing to do while those affected...well, their quality of life is diminishing because of bureaucracy and continued delays that should not even be an issue. I don't know if your company is fully aware or even cares how devastating this incredible delay is. Each day that passes without a DAYTRANA 30mg patch for my sons to wear to control their ADHD, is a day where they each miss out on achieving everything they were meant to dream, believe, and accomplish on that particular day in their lives. And ALOT OF DAYS HAVE GONE UNFULFILLED THIS YEAR. 2017 isn't looking too good to start out either after eleven phone calls this morning alone trying to find DAYTRANA. And now no one is even forecasting a possible date for delivery to pharmacies. The same goes for most, if not everyone else, who is waiting on their DAYTRANA PATCHES. This is an ABSOLUTE TRAVESTY. There is NO ONE to whom I can formally complain nor can I file a complaint against Noven Pharmaceuticals. What good would it do anyway? This comment essentially falls on deaf ears except for anyone who reads this page.
The last thing I have to say is this: the situation with the production issues regarding DAYTRANA PATCHES breaks my heart as a mother when I know the solution is out there and it is a simple, relatively easy fix. GREED just got in the way in my humble opinion.
Lisa
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Nancy
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Momma A.
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Lora Vogel
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Thank you and good luck to everyone who is searching high and low for this medication.
Talley Webb
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Cassandra L
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Novus - make more meds ASAP & get your manufacturing techniques up to date ASAP!
Cheryl Toon
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Margaret Kolb-Tavis
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Traci
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Melissa Winston
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Helen
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Mariella Heimberg
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Johnette Gaines
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