Par Pharma arm secures final nod for olanzapine, fluxoxetine hydrochloride capsules

Par Pharmaceutical Companies, Inc said its operating subsidiary Par Pharmaceutical, Inc has secured final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for olanzapine and fluxoxetine hydrochloride capsules.

These capsules are in the range of 3mg/25mg (eq base), 6mg/25mg(eq base), 6mg/50mg (eq base), 12mg/25mg (eq base) and 12 mg/50mg (eq base).

Olanzapine and fluxoetine hydrochloride is the generic version of Eli Lilly’s Symbax®    and is indicated to treat depressive episodes associated with bipolar I disorder in adults. 

Par has started shipping all strengths of the product. As per the IMS  Health data, the annual U.S. sales of olanzapine and fluxoetine hydrochloride capsules are around $80 million. The use of olanzapine and fluoxetine is contraindicated with monoamine oxidase inhibitors, primozide and thioridazine.

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. It also develops niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary’s two operating divisions namely Par Pharmaceutical and Strativa Pharmaceuticals

. The company initially traded on the New York Stock Exchange and this year, it agreed to be bought by the private equity company TPG Capital. It is based in U.S. with corporate headquarters in Woodcliff Lake, New Jersey and also has more facilities for research, manufacturing and distribution in Suffern, New York and Spring Valley, New York.