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 pa
'/>"/>

SOURCE Par Pharmaceutical Companies, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:9/23/2014)... Ultrasound devices enable physicians to image ... diagnose diseases and also these devices help surgeons ... surgeries. This report studies the global ultrasound devices ... type, technologies, applications and the major geographic markets. ... product type has been segmented as: cart/trolley based ...
(Date:9/23/2014)... , Sept. 23, 2014 Nuclear ... by 2015. Radiopharmaceuticals/ Nuclear are drugs ... nuclear imaging field to diagnose and treat diseases. ... ailments, Increasing awareness for radiopharmaceuticals, and ready availability ... this market. Furthermore, increased public awareness and use ...
(Date:9/23/2014)... CAESAREA, Israel , Sept. 23, 2014 /PRNewswire/ ... of the Dario™ Diabetes Management Solution, today announced ... placement offering consisting of shares of preferred stock ... this financing.  After estimated offering expenses, LabStyle expects ... from this financing. LabStyle intends ...
Breaking Medicine Technology:Ultrasound Devices Market (By Product Type, By Technology and By Application - Obstetrics and Gynecology, Cardiovascular, Abdominal and Others) - Global Industry Analysis, Size, Share, Growth, Trends & Forecast, 2013 - 2019 2Ultrasound Devices Market (By Product Type, By Technology and By Application - Obstetrics and Gynecology, Cardiovascular, Abdominal and Others) - Global Industry Analysis, Size, Share, Growth, Trends & Forecast, 2013 - 2019 3Global Nuclear Medicine Market - Growth, Trends & Forecasts (2014-2019) 2LabStyle Innovations Closes $4.2 Million Non-Brokered Private Placement Financing 2LabStyle Innovations Closes $4.2 Million Non-Brokered Private Placement Financing 3LabStyle Innovations Closes $4.2 Million Non-Brokered Private Placement Financing 4LabStyle Innovations Closes $4.2 Million Non-Brokered Private Placement Financing 5
(Date:9/23/2014)... -- Both drinking and getting drunk at an early ... high school students, a new study suggests. The ... who drink, could help expand alcohol-prevention efforts aimed at ... them from becoming binge drinkers, the researchers suggested. , ... use and progression to first heavy use as risk ...
(Date:9/23/2014)... Francisco, CA (PRWEB) September 23, 2014 Avid ... for original 1967 The Doors Eagle Auditorium Seattle concert posters. ... their album “Break On Through” that year. The Seattle Eagles ... to Hawley, “The Doors would return to Eagles Auditorium in ... July poster is not known and comes in three colors. ...
(Date:9/23/2014)... Grinnell Mutual seeks submissions from the ... Midwest. Working Together Making It Better will provide ... projects positively impacting their communities. , “So many ... communities a better places,” said Grinnell Mutual ... Baker. “Their leadership—as coaches, as volunteers, as mentors—help ...
(Date:9/23/2014)... 2014 (HealthDay News) -- Few children who ... behavioral therapy, and the rates vary six-fold across ... finds. Medication alone can manage symptoms for ... if they also receive behavioral therapy (psychotherapy), the ... data in more than 1,500 counties across the ...
(Date:9/23/2014)... recent Oregon survey about an exercise DVD that adds ... of elementary school students found it had a high ... offered clear advantages for overly sedentary educational programs. , ... by the Healthy Youth Program of the Linus Pauling ... , Brain Breaks leads children in 5-7 minute segments ...
Breaking Medicine News(10 mins):Health News:Younger Age at First Drink, Higher Odds for Problem Drinking: Study 2Health News:Younger Age at First Drink, Higher Odds for Problem Drinking: Study 3Health News:Grinnell Mutual Invites Submissions for Innovative, Collaborative Local Projects in Its Second Annual Working Together Making It Better Promotion 2Health News:Kids Taking ADHD Drugs Get Little Psychotherapy: Study 2Health News:'Brain Breaks' increase activity, educational performance in elementary schools 2Health News:'Brain Breaks' increase activity, educational performance in elementary schools 3
... Residents Access to Nursing Home, Assisted Living, Home ... Zip Code Statewide RICHMOND, Va., April 30 The cost ... is rising at a rate outpacing inflation, putting significant financial ... annual study by Genworth Financial. At the same time, ...
... Home, Assisted Living, Home Care and Adult Day Health Care ... The cost of long term ... putting significant financial pressure on those in or near retirement, ... the same time, the current economic downturn has led to ...
... Tissue density tied to chances of disease in middle-age and ... Breast cancer risk assessment and prevention should start much earlier ... examined breast cancer risk factors in young women. , ... their mothers found that breast tissue composition in young women ...
... diagnosed in U.S. have continued to be mild, officials ... World Health Organization on Wednesday raised the swine flu ... pandemic is imminent, and urged countries to implement their ... world health officials that the outbreak could trigger large ...
... Study Gives North Dakotans Access to Nursing Home, Assisted Living, ... Every Zip Code StatewideRICHMOND, Va., April 30 The cost ... a rate outpacing inflation, putting significant financial pressure on those ... Genworth Financial. At the same time, the current economic ...
... Study Gives New Mexico Residents Access to Nursing ... Costs in Nearly Every Zip Code Statewide RICHMOND, Va., April ... in New Mexico is rising at a rate outpacing inflation, ... according to an annual study by Genworth Financial. At ...
Cached Medicine News:Health News:Growth in Washington Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 2Health News:Growth in Washington Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 3Health News:Growth in Washington Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 4Health News:Growth in Texas Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 2Health News:Growth in Texas Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 3Health News:Growth in Texas Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 4Health News:Young Women's Breast Tissue Offers Clues to Cancer Risk 2Health News:WHO Raises Swine Flu Alert 2Health News:WHO Raises Swine Flu Alert 3Health News:WHO Raises Swine Flu Alert 4Health News:WHO Raises Swine Flu Alert 5Health News:WHO Raises Swine Flu Alert 6Health News:Growth in North Dakota Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 2Health News:Growth in North Dakota Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 3Health News:Growth in North Dakota Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 4Health News:Growth in New Mexico Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 2Health News:Growth in New Mexico Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 3Health News:Growth in New Mexico Long Term Care Costs Outpacing the Rate of Inflation, According to Annual Genworth Financial Study 4
... Temporary, Transvenous Pacing Lead System Features an ... lubricated guide catheter. The system is designed ... The system is disposable, for temporary single ... of 7 days or less. The lead ...
Automated slide maker and stainer...
... The new ... an electromagnetic braking ... years of reliable ... whisper-quiet operation. The ...
The Schiller treadmill ergometer is designed for stress tests, sports medicine and cardiology. It is equipped and tested with the latest safety system and has been manufactured under the stringent qu...
Medicine Products: