Par Pharmaceutical Companies, Inc., a privately held, US-based specialty pharmaceutical company, has received final approval from the US Food and Drug Administration (FDA) 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 (OCD).
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 US sales of Luvox CR are approximately $51 million.
Fluvoxamine maleate extended-release capsules are indicated for the treatment of 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 behaviours (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.
Co-administration 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.