WOODCLIFF LAKE, N.J., March 14, 2013 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for fluvoxamine maleate 100 mg and 150 mg extended-release (ER) capsules. Fluvoxamine maleate ER is the generic version of Jazz Pharmaceuticals' Luvox CR® and is indicated for the treatment of obsessive compulsive disorder. Par was the first company to have submitted a substantially complete ANDA containing a paragraph IV certification for fluvoxamine maleate 150 mg ER capsules and has been awarded 180 days of marketing exclusivity for this strength.
Par has begun shipping all approved strengths of the product. According to IMS Health data, annual U.S. sales of Luvox CR® are approximately $51 million.
Important Information About Fluvoxamine Maleate ER Capsules
Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thought, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated. The use of MAOIs intended to treat psychiatric disorders with fluvoxamine maleate extended-release capsules or within 14 days of stopping treatment with fluvoxamine maleate extended-release capsules are contraindicated because of an increased risk of serotonin syndrome. The use of fluvoxamine maleate extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.
A black box warning is associated with this product for the increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders. Refer to full prescribing information for complete boxed warning.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies, Inc.