Navigation Links
Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution

Ohm Laboratories to Market in OTC Private Label Market

PRINCETON, N.J., April 25 /PRNewswire/ -- Ohm Laboratories Inc (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1 mg/mL (OTC). 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 Children's Zyrtec Oral Solution (Allergy) and Children's Zyrtec Oral Solution (Hives-Relief), 1mg/mL of McNeil Consumer Healthcare. Total annual market sales for Cetirizine Hydrochloride Syrup as a prescription only product were $157 million (IMS - MAT: December 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. Other indications include relief from itching due to hives (urticaria).

"We are pleased to receive this final approval for Cetirizine Hydrochloride Oral Solution 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 as an over-the-counter product. This product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade participating in the OTC private label market," said Jim Meehan, Vice President of Sales and Distribution for Ohm Laboratories, a wholly owned subsidiary company 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.

*Children's Zyrtec(R) Oral Solution is a registered trademark of McNeil Consumer Healthcare.

CONTACTS: Charles M. Caprariello

Vice President, Corporate Communications

Ranbaxy Inc.

(609) 720-5615

Edwige Buteau

RF Binder Partners Inc.

(212) 994-7517

Caroline Mozingo

RF Binder Partners Inc.

(212) 994-7560

SOURCE Ranbaxy Laboratories Limited
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Ranbaxy Gains Approval to Manufacture and Market Cefuroxime Axetil for Oral Suspension
2. Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Tablets (OTC), 5mg and 10mg
3. Ranbaxy Receives Tentative Approval For Valsartan Tablets
4. Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspension, USP
5. Ranbaxy Gains Approval to Manufacture and Market Carvedilol Tablets in the U.S. Market
6. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
7. Michael E. DeBakey Receives Congressional Gold Medal
8. Perrigo Receives FDA Approval to Market Orange, Coated Nicotine Gum
9. Cadient Group Receives Multiple Awards at 2008 DTC National Advertising Awards
10. The National Exercise & Sports Trainers Association Receives Accreditation of Its Personal Fitness Trainer Certification From the National Commission for Certifying Agencies (NCCA)
11. PainCare Receives Notices From American Stock Exchange
Post Your Comments:
(Date:11/25/2015)... Indianapolis, IN (PRWEB) , ... November 25, 2015 ... ... clean water accessible for all, Water For Empowerment ™ attracts volunteers together ... on clean water by empowering women as key stakeholders in the process. The ...
(Date:11/25/2015)... Cokato, MN (PRWEB) , ... November 25, 2015 , ... ... Thanksgiving through Christmas Eve on several models of traditional and far-infrared saunas. ... . Nordic Spruce is the most traditional Finnish sauna wood, and Finnleo uses only ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... direct sauna parts and accessories. , Sauna accessories help improve the bather experience ... and personality. From basic styles for the purist looking for simplicity in design ...
(Date:11/25/2015)... ... November 26, 2015 , ... ... (AUC), European Union (EU), ANDI Pan African Centres of Excellence, and public R&D ... Nairobi (UNON) for the opening of the 5th African Network for Drugs and ...
(Date:11/25/2015)... ... , ... For the first time, Vitalalert is donating half of its earnings ... partnership between the two groups began in 2014 with Vitalalert pledging a portion of ... was founded in 1954 and is an international Christian-based health organization whose mission is ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... Nov. 26, 2015  The total global healthcare industry is ... 2015-2016. Latin America has the highest ... (excluding Japan ), is second with growth ... to face increased healthcare expenditure. In 2013-2014, total government funded ... 43.5% in 2008-2009 to 41.2% in 2013-2014. In real terms, ...
(Date:11/25/2015)... Nov. 25, 2015  The American Academy of ... (ACOG), and the March of Dimes cheered today,s ... Our Infants Act of 2015 (S.799), which ... newborns born exposed to drugs, such as opioids, ... introduction, all three organizations have worked together leading ...
(Date:11/25/2015)... Nov. 25, 2015 AAIPharma Services Corp./Cambridge ... of at least $15.8  Million to expand its ... NC . The expansion will provide additional ... the growing demands of the pharmaceutical and biotechnology ... expansion will provide up to 40,000 square feet ...
Breaking Medicine Technology: