| Ranbaxy
receives FDA approval to market Loperamide hydrochloride
and Simethicone tablets
First to File Status provides Ranbaxy with
180-day Marketing Exclusivity
Princeton, New Jersey – September 11,
2006
Ohm Laboratories Inc. (Ohm), a wholly owned subsidiary
of Ranbaxy Laboratories Limited (RLL) of New Delhi,
India, announced today that RLL has received approval
from the U. S. Food and Drug Administration to manufacture
and market Loperamide Hydrochloride and Simethicone
Tablets, 2 mg/125 mg (OTC). The Office of Generic Drugs,
U.S. Food and Drug Administration, has determined Ranbaxy’s
Loperamide Hydrochloride and Simethicone Tablets, 2
mg/125 mg (OTC) to be bioequivalent to the reference
listed drug (RLD) Imodium? Advanced Caplets, 2 mg/125
mg (OTC) of McNeil Consumer and Specialty Pharmaceuticals,
a Division of McNeil PPC, Inc. (McNeil).
Loperamide Hydrochloride and Simethicone Tablets (OTC)
are indicated for controlling symptoms of diarrhea plus
bloating, pressure, and cramps commonly referred to
as gas. Total sales of $25.3 million (IRI – MAT:
June 2006) were achieved for this product that is sold
in the OTC market.
According to Robert Haywood, Senior Director of OTC
Sales and Marketing of Ohm Laboratories, “Ohm
will again be a leading participant in the launch of
another successful and proven Loperamide formulation.
This will be marketed on a 180-day exclusive basis in
the private label/store brand segment of major U.S.
retailers and wholesalers. Ohm plans to ship when sufficient
supplies are produced to meet the demands of the marketplace.”
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 8 countries.
*Imodium® Advanced Caplets, is a registered
trademark of McNeil Consumer and Specialty Pharmaceuticals,
a Division of McNeil PPC, Inc. (McNeil)
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