Navigation Links
Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution
Date:4/25/2008

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:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... ... December 07, 2016 , ... Kenall Manufacturing, a leader in sealed healthcare ... The MPCNGX is a multi-function, sealed, LED luminaire that meets the needs of everyone ... when it’s needed. , A 2’ x 4’ model features four modes: ...
(Date:12/7/2016)... ... December 07, 2016 , ... OC87 Recovery Diaries ... schizophrenic mother in a unique, personal perspective through animation. , That woman ... addictive disorders at her private psychotherapy practice. Sheri’s mother, Pearl, lived with schizophrenia. ...
(Date:12/7/2016)... ... 2016 , ... Castle Dermatology Institute is now offering liquid facelifts with ... appearance to the face. Dr. Peyman Ghasri and Dr. Pedram Ghasri, San Fernando ... to rejuvenate and renew the facial appearance. , Sculptra is a highly effective ...
(Date:12/7/2016)... ... 07, 2016 , ... When it came time to blow out his candles on his 14th ... Pediatric Heart Transplant team at Joe DiMaggio Children’s Hospital surprised his family with ... 30th heart transplant recipient. , “He was playing at home, when we got the ...
(Date:12/7/2016)... TX (PRWEB) , ... December 07, 2016 , ... ... offering insurance and financial planning services to families and business owners in the ... funds on behalf of the Dallas Fallen Officer Foundation. , Established in 2009 ...
Breaking Medicine News(10 mins):
(Date:12/6/2016)...  Licenders is bringing their 100% all-natural lice removal service to ... at 203 13 th Street was specifically chosen to make ... "Our goal is to ease parents, stress and bring their ... children right back to class without skipping a beat. The best ... for the whole family," Licenders President Adie Horowitz states. ...
(Date:12/6/2016)... 6, 2016  "Blood Tests replace Surgical Biopsies. ... The Diagnostic, Monitoring and Screening Test opportunities ... is occurring using in vitro blood testing to ... impressive backing, has announced a single blood test ... faster than the market. New technology that definitively ...
(Date:12/6/2016)... 2016 Diabetes & Obesity Drug Development Pipeline ... disease cluster is currently dominated by therapeutics indicated for ... mellitus (T2DM), and the majority of the pipeline, in ... attributable to these indications. While products indicated for obesity ... are a large number of these products in the ...
Breaking Medicine Technology: