Navigation Links
Par Formulations (Formerly Edict Pharmaceuticals) Receives First ANDA Approval

WOODCLIFF LAKE, N.J., July 13, 2012 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its operating subsidiary, Par Formulations Private Limited, (formerly Edict Pharmaceuticals Private Limited), received its first USFDA approval for Labetalol HCl Tablets 100 mg, 200 mg & 300 mg, the generic version of Trandate®.  Par anticipates the product to be available in August.

Par Pharmaceutical acquired Edict Pharmaceuticals, based in Chennai, India, in February 2012. 

Important information about Labetalol HCl Tablets
Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Labetalol hydrochloride tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product.  Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a 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 higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.  For press releases and other company information, visit

Safe Harbor Statement
Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein.  Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions.  Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.

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

Related medicine technology :

1. Halozymes Ultrafast Insulin Formulations Improved Postprandial Glycemic Control in Patients Living with Type 1 Diabetes: Phase 2 Study Results Presented at ADA 2012
2. Biodel Obtains Exclusive License to Aegis Therapeutics Technologies for Development and Commercialization of Glucagon Pharmaceutical Formulations
3. GlaxoSmithKline Share Their Insight on Understanding DDI With a View to Better Prediction and Control
4. Telik Announces the Publication of Two Reports in the Journal Of Hematology & Oncology Describing the Results of a Clinical Study of Telintra® in Combination With Revlimid® and a Genomic Study Designed to Identify Genes That Predict Response to Teli
5. Integrity Life Sciences Receives CE Mark and ISO Certifications for the Integrity Spinal Care System Medical Device
6. Kimberly-Clark Health Care Receives FDA Clearance For KIMGUARD ONE-STEP Sterilization Wrap Portfolio With One-Year Maintenance Of Package Integrity And Amsco V-PRO maX (Flexible Cycle)
7. Dehaier Medical Receives Software Copyrights for Four Proprietary Technologies
8. Watsons Generic ARTHROTEC(R) Receives FDA Approval
9. Sofie Biosciences receives $1M Phase II SBIR grant from the DOE
10. Asthmapolis Receives FDA Clearance for Asthma Inhaler Sensor Technology and Accompanying Software System
11. Integrity Life Sciences Receives US FDA 510(k) Clearance for its Integrity Spinal Care System Medical Device
Post Your Comments:
(Date:6/23/2016)... 2016  In a startling report released today, National Safety ... lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... how states are tackling the worst drug crisis in recorded U.S. ... Kentucky , New Mexico , ... Of the 28 failing states, three – Michigan ...
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... , June 23, 2016 , ... Thursday, July 7, 2016 , , , , LOCATION: , ... , , , , EXPERT PANELISTS:  , , , Frost ... Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh ... The global pharmaceutical industry is witnessing an exceptional era. Several ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... A recent article published June 14 on E Online details ... to state that individuals are now more comfortable seeking to undergo not only the ... and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) notes ...
(Date:6/24/2016)... ... ... crisis. Her son James, eight, was out of control. Prone to extreme mood shifts and ... him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife on ... say he was going to kill them. If we were driving on the freeway, ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with ... Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... Vegas, Nevada (PRWEB) , ... June 24, 2016 ... ... Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and processing ... Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of ...
Breaking Medicine News(10 mins):