Home / Drugs / gabapentin enacarbil

gabapentin enacarbil

FDA Drug Profile — Horizant

Drug Details

Generic Name
gabapentin enacarbil
Brand Names
Horizant
Application Number
NDA022399
Sponsor
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
NDC Codes
2
Dosage Forms
TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
GABAPENTIN ENACARBIL

Indications and Usage

1 INDICATIONS AND USAGE HORIZANT is indicated for: treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. ( 1.1 ) management of postherpetic neuralgia (PHN) in adults. ( 1.2 ) 1.1 Treatment of Restless Legs Syndrome HORIZANT ® is 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. 1.2 Management of Postherpetic Neuralgia HORIZANT is indicated for the management of postherpetic neuralgia (PHN) in adults.