PRINCETON, N.J., Dec. 31 /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