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:6/24/2016)... 2016 Research and Markets has announced ... Diagnostic Tests" report to their offering. ... The World Market for Companion Diagnostics covers ... Market analysis in the report includes the following: ... Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/24/2016)... Tenn. , June 24, 2016  Arkis ... providing less invasive and more durable cerebrospinal fluid ... in funding.  The Series-A funding is led by ... Lighthouse Fund, and other private investors.  Arkis, new ... neurosurgical instrumentation and the market release of its ...
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 27, 2016 , ... Quality metrics are ... in many ways they remain in the eye of the beholder, according to experts ... publication of The American Journal of Managed Care. For the full issue, click ...
(Date:6/26/2016)... Viejo, California (PRWEB) , ... June 26, 2016 , ... ... Final Cut Pro X. , "Film editors can give their videos a whole new ... said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels contains ...
(Date:6/26/2016)... Charlotte, NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind ... able to be personalized through a fitness app. The fitness app plans to fix the ... solutions currently only offer a one size fits all type program , They ...
(Date:6/25/2016)... ... 2016 , ... Experts from the American Institutes for Research ... June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR experts ... planning, healthcare costs and patient and family engagement. , AIR researchers will be ...
(Date:6/25/2016)... , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on ... Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ability ... fumigation is not a common occurrence, but a necessary one in the event that lice ...
Breaking Medicine News(10 mins):