Navigation Links
Par Pharmaceutical Begins Shipment of KHEDEZLA (desvenlafaxine) Extended-release Tablets, 50 mg and 100 mg
Date:9/23/2013

WOODCLIFF LAKE, N.J., Sept. 23, 2013 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has begun shipping KHEDEZLA (desvenlafaxine) Extended-release (ER) Tablets, 50 mg and 100 mg.  Par's development partner, Osmotica Pharmaceutical Corp., received approval for its New Drug Application (NDA) for KHEDEZLA ER Tablets from the U.S. Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.  KHEDEZLA is indicated for the treatment of major depressive disorder (MDD).  KHEDEZLA provides patients and physicians with additional options in the treatment of major depressive disorder. 

Osmotica's NDA included comparative bioequivalence testing against Pfizer's PRISTIQ® (desvenlafaxine) Extended-Release Tablets. KHEDEZLA is not generically substitutable for PRISTIQ 50 mg and 100 mg tablets. According to IMS Health data, annual U.S. sales of PRISTIQ are approximately $614 million. 

Under terms of its agreement with Osmotica, Par will market, sell and distribute KHEDEZLA in the United States. Par will share profits from the sales of the product with its development partner.  

Important Information about KHEDEZLA ER Tablets 
A black box warning is associated with this product regarding increased risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants.  All persons taking KHEDEZLA should be monitored for worsening and emergence of suicidal thoughts and behaviors.  KHEDEZLA is not approved for use in pediatric patients. Refer to full prescribing information for complete boxed warning.

KHEDEZLA (desvenlafaxine) Extended-release Tablets are contraindicated in patients who are hypersensitive to desvenlafaxine succinate, venlafaxine hydrochloride or to any component of the product.  Angioedema has been reported in patients treated with desvenlafaxine.

The use of MAOIs intended to treat psychiatric disorders with KHEDEZLA or within 7 days of stopping treatment with KHEDEZLA is contraindicated because of an increased risk of serotonin syndrome.  The use of KHEDEZLA within 14 days of stopping a MAOI intended to treat psychiatric disorders is also contraindicated.  Starting KHEDEZLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.

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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
2. Immune Pharmaceuticals Inc. Trading Symbol is Now IMNP on Both NASDAQ OMX Stockholm Exchange and OTCQX Trading Platform
3. Isis Pharmaceuticals to Conduct Webcast and Conference Call to Discuss ISIS-APOCIII Rx Phase 2 Data
4. Harwood Feffer LLP Announces Investigation of Transcept Pharmaceuticals, Inc.
5. New Pharmaceutical Product Launch Spend: Developing Competitive Launch and Pre-launch Budgets to Ensure a Successful Market Entry
6. Avanir Pharmaceuticals Announces Publication of AVP-825 Pharmacokinetic Data in Journal "Headache"
7. Auxilium Pharmaceuticals, Inc. Raises $50 Million In Additional Financing
8. Thomson Reuters Reveals New Strategies for Navigating Big Data in the Pharmaceutical Industry
9. Rafarma Pharmaceuticals, Inc. (RAFA) announces plans for PCAOB-Registrant Audit and Streamlining of Corporate Structure to Upgrade Market Listing.
10. Legal Actions, Quarterly Dividends, Collaborations, and New Appointments - Research Report on Johnson & Johnson, Zoetis, Abbott, Teva Pharmaceuticals, and Baxter
11. Amgen and Onyx Pharmaceuticals Announce Early Termination of HSR Waiting Period for Amgens Acquisition of Onyx
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, ... tissues, announced three leadership team developments today:   ... ... ... Veteran medical device executive Josh Stopek , PhD, ...
(Date:9/18/2017)... Mich. , Sept. 18, 2017  PMD Healthcare ... Specialty Pharmacy of Kalamazoo, Mich. , ... hub service that expedites and streamlines patient and provider ... PD 2.0, and wellness management services.  ... device used to measure lung function for a variety ...
(Date:9/13/2017)... --  OrthoAtlanta has been named the official orthopedic and ... for the 2018 College Football Playoff (CFP) National Championship to ... in Atlanta, Georgia . OrthoAtlanta is proud ... participating in many activities leading up to, and including the ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... Ky. (PRWEB) , ... October 13, 2017 , ... The ... MPH to become its next President and Chief Executive Officer, succeeding Dr. James C. ... CEO Elect beginning July 1, 2018 until Dr. Puffer’s retirement at the end of ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate professor ... prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. The ...
(Date:10/13/2017)... LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for care ... is the 90-day elimination period, when the family pays for care, is often waived, ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
Breaking Medicine News(10 mins):