Generic Nuvigil Gets FDA Nod

Generic Nuvigil Abbreviated New Drug Application Gets FDA Nod – 12/02/2016

What makes this “wakefulness” drug unusual is that it is not related to amphetamine (like Adderal is). It can be useful off-label to combat the crushing fatigue that comes with chronic pain.

Breckenridge Pharmaceutical, Inc. has announced that its Abbreviated New Drug Application (ANDA) for armodafinil tablets has received final approval from the FDA.

The tablets, which are being created in 50-mg, 150-mg and 250-mg doses, are generic versions of Nuvigil from Cephalon, the subsidiary of Teva Pharmaceutical Industries.

Armodafinil is designed to improve wakefulness in adult patients with excessive sleepiness due to obstructive sleep apnea, narcolepsy, or shift work disorder.

 

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6 thoughts on “Generic Nuvigil Gets FDA Nod

  1. BirdLoverInMichigan

    I tried Nuvigil. At first, I thought it was an exciting and excellent drug. It gave me energy, and I could see things in a much more intense visual way.

    But after three or four doses on that many days, I suddenly saw this smear in the middle of the vision of my right eye. Turns out, I developed a permanent floater that’s never fallen down beneath my line of vision.

    This was five years ago. One ophthalmologist said there are optical risks with these types of drugs. I was diagnosed with a posterior vitreous rupture. It’s likely my also having Ehlers Danlos Syndrome put me at higher risk.

    I’d caution anyone with a connective tissue disorder to avoid these types of drugs. As many of us with EDS know, we end up with a lot of complications others usually don’t face.

    Liked by 1 person

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    1. Zyp Czyk Post author

      How interesting! I used to take NuVigil until it became unaffordable (as so many other better drugs have become) years ago. I also had a vitreous detachment, but I can’t remember if it was during the time I was taking NuVigil, but now I wonder.

      I looked it up and found a reassuring statement from the National Eye Institute: https://nei.nih.gov/health/vitreous/vitreous

      “In most cases, a vitreous detachment, also known as a posterior vitreous detachment, is not sight-threatening and requires no treatment.”

      Floaters are a mystery and I’ve had them come and go, even though some lasted for years. They were worst when I was in my early 20’s, long before I took NuVigil.

      “One symptom of a vitreous detachment is a small but sudden increase in the number of new floaters. This increase in floaters may be accompanied by flashes of light (lightning streaks) in your peripheral, or side, vision. In most cases, either you will not notice a vitreous detachment, or you will find it merely annoying because of the increase in floaters.”

      These are exactly the symptoms I experienced several years ago, but there were no permanent changes.

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  2. Shirley Poole

    I have been taking nuvigil for close to 4 years . In March insurance company change name brand to gernic . I notice pill was smaller but did not question my drugest and I continue on. I became sleeping more standing at kitchen sink I no longer drive because I lost most of eye sight in Jan 2016. O suffer from other things. In July I had found my self and had been for month extremely fatigue in more cronic pain extremely depressed because I just did not have enough to get out of house I on went to Dr appointment I was sleeping from 16 to 20 a day. Seen all my Dr complaining of severe fatigue . Lung , heart, RA, and my General Dr. A interest. Number of test change in medication. Increase pain med placed on antidepression med. Middle part of July I noticed on my bottle it was gernic because I with out my Dr permition desided I would increase dosage went from normally dose 150 mg day to 225 then to 300 no help even ordered so something off line hoping to help with my narcolepsy . The off line stuff helped more but had to increase to over doble recommend dosage. Findly called my Dr and got some samples of TRUE Nuvigil with in 48 hours I able to get out of bed . I’m more motion I get out more less depressed cut back on pain meds less shortness of bread . GERNIC NUVIGIL DONT WORK . Manufactured by Lupin . Complained to them reply they meet the requirement. They cost me months of my life really though I was dieing. Fl Blue alternative to the Nuvigil .ADD Drugs don’t no were close to the same oh yah my memory and brain fog is better. I had started thinking I was starting to have dementia.

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      I know how you feel because I’ve been disappointed by generic drugs too.

      A symptom will come roaring back and only later will I realize it’s because my prescription changed to generic – or sometimes just even a different generic.

      I think some of us are far more sensitive to such changes and that most people don’t have such problems with the changes. That’s why nothing gets done about it – we are just statistical outliers.

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