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:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in ... ways they remain in the eye of the beholder, according to experts who offered ... The American Journal of Managed Care. For the full issue, click here . ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is ... a fitness app. The fitness app plans to fix the two major problems leading the ... one size fits all type program , They don’t eliminate all the reasons ...
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... report to their offering. ... failure, it replaces the function of kidneys by removing the ... the treatment helps to keep the patient body,s electrolytes such ... Increasing number of ESRD patients & substantial healthcare expenditure on ...
Breaking Medicine Technology: