| Ranbaxy
Receives Final approval to manufacture and market cetirizine
hydrochloride tablets (OTC), 5mg and 10mg.
Princeton, NJ – December 31, 2007
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 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® Allergy tablets, 5mg
and l0mg and Zyrtec® 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, a Ranbaxy Group Company.
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® is a registered trademark of UCB Pharma,
S.A.
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