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.