Navigation Links
Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Tablets (OTC), 5mg and 10mg
Date:12/31/2007

PRINCETON, N.J., Dec. 31 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL), announced today that the company has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ohm formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Zyrtec(R) Allergy tablets, 5mg and l0mg and Zyrtec(R) Hives Relief tablets, 5mg and 10mg by Pfizer Pharmaceuticals Inc. Total annual market sales for Cetirizine Hydrochloride Tablets as a prescription only product were $1.3 billion (IMS - MAT: September 2007).

Cetirizine Hydrochloride is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

"We are pleased to receive this final approval for Cetirizine Hydrochloride Tablets (OTC) 5mg and 10mg, that has proven its clinical value and utility in both adults and children. We are pleased to offer this preferred formulation that will meet the needs of all patients who need this medication in response to allergic reactions. This OTC product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade," said Jim Meehan, Vice President of Sales and Distribution for Ohm Laboratories Inc, a wholly owned subsidiary of RLL.

Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited ("RLL"), India's largest pharmaceutical company. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.

Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

*Zyrtec(R) is a registered trademark of UCB Pharma, S.A.

CONTACTS: Charles M. Caprariello, Vice President, Corporate

Communications,

Office: (609) 720-5615

Cell: (609) 462-7354

Anuj Baveja

RF Binder Partners Inc.

Office: (212) 994-7552

Cell: (551) 587-2233


'/>"/>
SOURCE Ranbaxy Laboratories Limited
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
2. Ranbaxy Gains Approval to Manufacture and Market Carvedilol Tablets in the U.S. Market
3. Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspension, USP
4. Ranbaxy Receives Tentative Approval For Valsartan Tablets
5. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
6. DaVita Receives Civil Complaint
7. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
8. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
9. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers
10. UT Southwesterns obesity research receives $22 million NIH Roadmap grant
11. Temple Emergency Medicine receives $1.8M to find best MRSA treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... ... fertility once they have been diagnosed with endometriosis. These women need a treatment ... also require a comprehensive approach that can help for preservation of fertility and ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... Aliso Viejo, California (PRWEB) , ... June 25, 2016 , ... ... preset to fit their specific project," said Christina Austin - CEO of Pixel Film ... all fully customizable and all within Final Cut Pro X . Simply select ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of ... award to iHire in recognition of their exemplary accomplishments in worksite health promotion. , ... Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Revolutionary technology includes ... Oticon , industry leaders in advanced audiology and hearing ... Oticon Opn ™, the world,s first internet connected hearing ... IoT devices.      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ... number of ,world firsts,: , TwinLink™ - ...
(Date:6/23/2016)... Research and Markets has announced ... Analysis (United States, China, Japan, Brazil, United Kingdom, Germany, ... offering. Surgical Procedure ... planners, provides surgical procedure volume data in a geographic ... in-depth analysis of growth drivers and inhibitors, including world ...
(Date:6/23/2016)... , June 23, 2016  The National ... has joined the health policy research organization as ... Romano , MD, senior vice president and chief ... company,s representative on the NPC Board of Directors. ... pleased that Mallinckrodt has joined us in support ...
Breaking Medicine Technology: