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

By Admin
Par Pharmaceutical Companies, Inc said its operating subsidiary Par Pharmaceutical, Inc has secured final approval from the U.S. Food and Drug Administ...

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.

Share
Share

Featured Articles

Hyfe AI uses acoustic AI in its digital cough monitoring

Hyfe uses acoustic AI in its digital cough monitoring. Dr. Joe Brew, Co-Founder & CEO of Hyfe AI, tells us more about coughing technology post-COVID-19

Siemens: smart finance to help medical technology growth

Penny Pinnock, Business Development Manager at Siemens Financial Services UK, discusses how adopting digital technology can support the healthcare sector

Healthcare Digital news roundup: prostate cancer & AI

This week in Healthcare Digital, we heard from experts in the sector: Trevor Dearing from Illumio, Avenda Health’s Brit Berry-Pusey & Vish Charan of Abbott

Lexica shares post-COVID-19 digital healthcare trends

Digital Healthcare

Medical devices expanding senior healthcare innovation

Medical Devices & Pharma

Abbott’s CRM medical devices can help cardiac arrhythmia

Medical Devices & Pharma