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:3/24/2017)... 2017  Eli Lilly and Company (NYSE: ... $850 million in its U.S. operations in 2017. ... enterprise, including research laboratories, manufacturing sites, and general ... by demand for Lilly products, as well as ... targeting cancer, pain, diabetes and other unmet medical ...
(Date:3/24/2017)... -- The Board of Directors of Nordic Nanovector ... including the complete 2016 Annual Accounts with notes. The report ... website in the section Investor Relations/Reports and presentations/Annual Reports. ... For further ... Financial Officer Cell: +47-91-51-95-76 Email: ir@nordicnanovector.com ...
(Date:3/23/2017)... HICKORY, N.C. , March 23, 2017  Transportation ... accolades as an end-to-end supply chain management firm with ... of Consumer Product Solutions Rick Zaffarano was ... Star of the Supply Chain by the only publication ... the global food supply chain. "Rick has ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... Vighter established ... same time by providing Prehospital Trauma Life Support (PHTLS) course scholarships to four ... prehospital trauma education developed in cooperation with the American College of Surgeons to ...
(Date:3/24/2017)... ... March 24, 2017 , ... Digital Scientists, a software ... announce the opening of a Greenville, South Carolina location. The lab has ... in Greenville. , “We’ve been working with South Carolina clients for years from our ...
(Date:3/24/2017)... ... ... Texas Physical Therapy Specialists (TexPTS) is pleased to announce the opening ... is the group’s 7th location in San Antonio and 23rd in Texas. Dr. ... from the clinic, which opened March 22, 2017. , The team of ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... Arizona’s Premier Center for Shamanic Healing and Spiritual Awakening, proudly presents her ... 9--24, 2017. This sacred and spiritual journey during the Summer Solstice will ...
(Date:3/24/2017)... , ... March 24, 2017 , ... ... announce that they are now offering treatments for sleep apnea and TMJ at ... offices. Sleep apnea , specifically the obstructive type, is increasingly being treated ...
Breaking Medicine News(10 mins):