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:12/2/2016)... ... December 02, 2016 , ... The annual time frame to change Medicare health ... is ending December 7th. Currently-enrolled Medicare beneficiaries who are looking to switch from their ... D) need to make changes during this period order for their new policy to ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... More than ... and while 84 percent of parents report speaking with their child about sex related ... sexually transmitted diseases. , Mediaplanet is proud to announce the launch of its second ...
(Date:12/2/2016)... ... December 02, 2016 , ... Sourced from the Isbre Springs beneath the 5,000 ... unmatched natural purity of just 6 ppm TDS (Total Dissolved Solids) in addition to ... been available in several ShopRite and FoodTown stores in NJ and received rave comments ...
(Date:12/2/2016)... Miami, FL (PRWEB) , ... December 02, 2016 ... ... over 5,100 hot meals to needy individuals and families from eight different sites ... Florida on Thanksgiving Day. Over 1,000 volunteers worked very hard on Thanksgiving morning ...
(Date:11/30/2016)... , ... November 30, 2016 , ... ... they now offer a comprehensive in-house dental plan for all patients. Understanding that ... a plan that gives patients a number of perks, including discounts on many ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... YORK , December 2, 2016 ... Braces & Support) is Expected to Gain a Significant Market ... to Orthopedic Ailments  ... , According to ... Study on Medical Implants Sterile Packaging: Clamshell Product Type Segment ...
(Date:12/2/2016)... On Thursday, the NASDAQ Composite and ... the Dow Jones Industrial Average managed to stay in green. ... which prompted Stock-callers this morning to look at the performances ... NUVA ), Smith & Nephew PLC (NYSE: SNN ... Cesca Therapeutics Inc. (NASDAQ: KOOL ). You can ...
(Date:12/2/2016)... -- The concept of rare diseases and the idea that ... has been taking shape in Europe ... initiatives related to orphan medicinal products have been emerging at ... states individually. Many member states in the EU have led ... medicinal products, the result of which took the shape of ...
Breaking Medicine Technology: