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.



4 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

    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:

      “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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