milnacipran hydrochloride

FDA Drug Profile — Savella, Milnacipran Hydrochloride

milnacipran hydrochloride is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including Savella, Milnacipran Hydrochloride. Available dosage forms: tablet, film coated, kit.

Drug Details

Generic Name
milnacipran hydrochloride
Brand Names
Savella, Milnacipran Hydrochloride
Application Number
NDA022256
Sponsor
Cardinal Health 107, LLC
NDC Codes
14
Dosage Forms
TABLET, FILM COATED, KIT
Routes
ORAL
Active Ingredients
MILNACIPRAN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Milnacipran hydrochloride tablets are indicated for the management of fibromyalgia. Milnacipran hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. Milnacipran hydrochloride tablets are selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia ( 1 ). Milnacipran hydrochloride tablets are not approved for use in pediatric patients ( 1 ).