Navigation Links
Par Pharmaceutical Receives Final Approval To Market Tretinoin Capsules
Date:10/25/2012

WOODCLIFF LAKE, N.J., Oct. 25, 2012 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that its operating subsidiary, Anchen Pharmaceuticals, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for tretinoin capsules, 10 mg.  Tretinoin capsules is the generic version of Vesanoid® capsules and is used in the treatment of acute promyelocytic leukemia.  Par expects to begin shipping the product before the end of the month. 

According to IMS Health data, annual U.S. sales of tretinoin are approximately $29 million. 

Important Information about Tretinoin Capsules

Tretinoin Capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARalpha gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline based chemotherapy is contraindicated.  Tretinoin is for the induction of remission only.  The optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for APL after completion of induction therapy with tretinoin. 

Tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids.  

Patients with acute promyelocytic leukemia (APL) are at high risk in general and can have severe adverse reactions to tretinoin.   About 25% of patients with APL treated with tretinoin have experienced a syndrome called the retinoic-acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure.  During tretinoin treatment about 40% of patients will develop rapidly evolving leukocytosis.  Patients who present with high WBC at diagnosis (. 5x109/L) have an increased risk of a further rapid increase in WBC counts.  Rapidly evolving leukocytosis is associated with a higher risk of life threatening complications.  There is also a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy.  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.  Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.  For press release and other company information, visit www.parpharm.com


'/>"/>
SOURCE Par Pharmaceutical Companies
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Report Presents a Framework for Successful New Oncology Product Launches in the Pharmaceutical Sector
2. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
3. Pharmaceutical Industry Service Company Awarded The UKs Most Prestigious Business Accolade in Recognition of Outstanding Achievement in International Trade
4. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
5. Simcere Pharmaceutical Group to Announce First Quarter 2012 Financial Results on Wednesday, May 9, 2012
6. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
7. Thomson Reuters Launches New Mobile Oncology Decision Support Solution for R&D Pharmaceutical Leaders
8. Amgen to Acquire Mustafa Nevzat, a Leading Privately Held Turkish Pharmaceutical Company
9. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
10. Icahn Issues Statement Regarding Amylin Pharmaceuticals
11. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... WOONSOCKET, R.I. , April 20, 2017 /PRNewswire/ ... (NYSE: CVS), today unveiled a new store design ... new assortment of healthier food, health-focused products and ... the store to help customers discover new offerings. ... represent the next evolution of the customer experience ...
(Date:4/20/2017)... Research and Markets has announced the addition of ... Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, ... ... at US$ 7,167.6 Mn in 2015, and is expected to ... of 5.6% from 2016 to 2024. The ...
(Date:4/20/2017)... Research and Markets has announced the addition of the ... Service (Manufacturing, Research), By Country, (Brazil, Mexico, Colombia, Argentina, Chile, ... their offering. ... Latin American pharmaceutical contract manufacturing services market is anticipated to ... registration cost in Latin American countries and continuous economic growth ...
Breaking Medicine Technology:
(Date:4/25/2017)... , ... April 25, 2017 , ... ... a modern procedure that achieves results in a fraction of the time as ... Vegas, NV, with Significance Dental Specialists, now offers this revolutionary treatment with or ...
(Date:4/25/2017)... RESTON, VIRGINIA (PRWEB) , ... April 25, 2017 ... ... scientists leading the way in unveiling cutting-edge birth defects research related to Zika ... recognized by the world’s premier society for this important science. , ...
(Date:4/25/2017)... ... 2017 , ... Buyers and sellers in the thriving multi-billion dollar cannabis marketplace ... help but be heartened by the industry’s current surge. But another thing that unifies ... smell.” At last they can simply, safely and effectively end their aroma anguish ...
(Date:4/25/2017)... (PRWEB) , ... April 25, 2017 , ... ... addition of predictive analytics to its patient care management module. Using this new ... before a patient has been initiated on continuous positive airway pressure (CPAP), oral, ...
(Date:4/25/2017)... ... April 25, 2017 , ... There is no better place in South Florida ... report in the May issue of Consumer Reports focused on heart health. , ... achieved during and after coronary bypass and aortic valve replacement procedures. , Consumer ...
Breaking Medicine News(10 mins):