Par Pharmaceutical Begins Shipment of Generic Luvox CR®

           Par Pharmaceutical Begins Shipment of Generic Luvox CR®

Company Awarded 180 Days Marketing Exclusivity for 150 mg Strength

PR Newswire

WOODCLIFF LAKE, N.J., March 14, 2013

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.

Website: http://www.parpharm.com
Contact: Stephen Mock of Par Pharmaceutical Companies, Inc., +1-201-802-4033