| Ranbaxy
receives FDA approval to market Loratadine Orally Disintegrating
Tablets
Princeton, New Jersey – April 12, 2007
Ohm Laboratories Inc. (Ohm), a wholly owned subsidiary
of Ranbaxy Laboratories Limited (RLL), announced today
that RLL has received approval from the U. S. Food and
Drug Administration to manufacture and commercialize
its Loratadine Orally Disintegrating Tablets, 10mg.
The antihistamine previously made the switch from the
prescription to the OTC market. The Division of Bioequivalence
has determined Ranbaxy’s Loratadine Orally Disintegrating
Tablets, 10 mg, to be bioequivalent to the reference
listed drug, Claritin® Reditabs®, 10 mg, of
Schering Plough Healthcare Products. Loratadine is a
long-acting antihistamine agent, which, in the orally
disintegrating form, has annual sales of $58.7 million
(IRI - MAT: December 2006).
Loratadine is indicated for the temporary relief of
runny nose, sneezing, itching of the nose or throat,
itchy watery eyes due to hay fever or other respiratory
allergies in adults and children six years of age and
older.
“With Loratadine, Ohm will be launching another
OTC product offering that represents a molecule with
value and utility, marketed in the private label or
store brand segment of the U.S. healthcare system. This
will provide greater access to a product with a proven
track record of clinical success as a non-sedating antihistamine,
made available at an affordable cost to retail/wholesale/healthcare
trade classes, and ultimately the OTC consumer market.
Product will be available during the later part of June
of this year,” according to Robert Haywood, Senior
Director of OTC Sales and Marketing, Ohm Laboratories.
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 9 countries.
Claritin® Reditabs® is a registered trademark
of Schering Plough Healthcare Products
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