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:10/13/2017)... Pekin, IL (PRWEB) , ... October 13, 2017 ... ... Foundation, which established the certification process to promote standards of excellence for the ... iaedp™ Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at ...
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & Associates ... special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to date ... elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded by ...
(Date:10/13/2017)... RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... annual Holly Day Market. Featuring a collection of specialty vendors and unique items from ... of personalized and quality-focused health and wellness services offered by the VNA. The ...
(Date:10/13/2017)... ... 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, ... and least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints ... for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says ...
(Date:10/13/2017)... ... 13, 2017 , ... “The Journey: From the Mountains to the Mission Field”: ... souls in the Philippines. “The Journey: From the Mountains to the Mission Field” is ... Bible. She has taught all ages and currently teaches a class of ladies at ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... 27, 2017  Commended for their devotion to personalized service, ... as number one in the South Florida Business Journal,s 50 ... 5000 yearly list, the national specialty pharmacy has found its ... will soon be honored by SFBJ as the 2017 ... Set to receive his award in October, Bardisa said ...
(Date:9/23/2017)... -- Janssen Biotech, Inc. (Janssen) announced today that it ... Food and Drug Administration (FDA) for the Biologics License ... of moderately to severely active rheumatoid arthritis (RA). The ... to further evaluate the safety of sirukumab in the ... "We are disappointed by ...
(Date:9/19/2017)... Sept. 19, 2017   ZirMed Inc ., a recognized ... announced that it has been ranked #1 by its users ... Rankings 2017 User Survey. ZirMed was recognized as the ... hospitals and medical centers over 200 beds and holds one ... technology user survey history. ...
Breaking Medicine Technology: