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FDA
Registration Date 2 Dec 2016
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Horizant

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Medicine Pharmaceuticals Product Number : 53451-0103-9

Analgesic

Drug Information

Generic
gabapentin enacarbil
NDC Code
53451-0103-9
Drug Class
Gamma-aminobutyric acid analogs
Therapeutic Class
Analgesic
Dosage form
tablet
Route of Administration
Oral
Therapeutic Area
1.Legs Syndrome (RLS) 2.postherpetic neuralgia

Indication

Syndrome HorizantĀ® (gabapentin enacarbil) Extended-Release Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night. Management of Postherpetic Neuralgia Horizant (gabapentin enacarbil) Extended-Release Tablets are indicated for the management of postherpetic neuralgia (PHN) in adults.

Benefit

Prior to the U.S. FDA approval of HORIZANT (gabapentin enacarbil) in April 2011, adult patients with moderate-to-severe primary restless legs syndrome, or RLS, had one class of drug that was approved in the United States to treat their condition. When HORIZANT was introduced to the market, the door was opened for those adult patients to try a new class of drug for treatment of their moderate-to-severe primary RLS. In June 2012, the FDA also approved HORIZANT for the management of pain in adult patients with postherpatic neuralgia, or PHN. We believe that HORIZANT is one more option for patients that need to manage the pain associated with PHN.