Par Pharmaceutical Begins Shipment of Generic Symbyax®
WOODCLIFF LAKE, N.J., Nov. 28, 2012
WOODCLIFF LAKE, N.J., Nov. 28, 2012 /PRNewswire/ --Par Pharmaceutical
Companies, Inc. today announced that its Par Pharmaceutical, Inc. operating
subsidiary has received final approval from the U.S. Food and Drug
Administration for its Abbreviated New Drug Application for olanzapine and
fluoxetine hydrochloride capsules, 3 mg/25 mg (eq base), 6 mg/25 mg (eq base),
6 mg/50 mg (eq base), 12 mg/25 mg (eq base) and 12 mg/50 mg (eq base).
Olanzapine and fluoxetine hydrochloride is the generic version of Eli Lilly's
Symbyax^® and is indicated for the acute treatment of depressive episodes
associated with Bipolar I Disorder in adults.
Par has begun shipping all strengths of the product. According to IMS Health
data, annual U.S. sales of olanzapine and fluoxetine hydrochloride capsules
are approximately $80 million.
Important Information about Olanzapine and Fluoxetine Hydrochloride Capsules
The use of olanzapine and fluoxetine is contraindicated with monoamine oxidase
inhibitors (MAOI), pimozide and thioridazine. A black box warning is
associated with this product regarding suicidality and antidepressant drugs
and increased mortality in elderly patients with dementia-related psychosis.
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.
Contact: Stephen Mock, Par Pharmaceutical Companies, Inc., +1-201-802-4033
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