milnacipran hydrochloride
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 FETZIMA ® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established. FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults ( 1 ). Limitation of Use : FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established ( 1 ).