The US Food and Drug Administration (FDA) has approved Par Pharmaceutical Companies' abbreviated new drug application (ANDA) for fluvoxamine maleate 100mg and 150mg extended-release (ER) capsules.
Fluvoxamine maleate ER capsules are indicated for the treatment of obsessive compulsive disorder (OCD), which is characterized by recurrent and persistent ideas or images that are recognized by the person as excessive or unreasonable.
The US-based specialty pharmaceutical company was awarded 180 days of marketing exclusivity for fluvoxamine maleate 150mg ER capsules.
Fluvoxamine maleate ER is the generic version of Jazz Pharmaceuticals' Luvox CR.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-par-pharma-fluvoxamine-maleate-er-capsules-anda-150313
