RANBAXY FIRST TO GAIN APPROVAL
TO MANUFACTURE AND MARKET CLARITHROMYCIN FOR ORAL SUSPENSION,
USP
Ranbaxy One of Few Companies to Offer Both Suspension
and Tablet Forms Princeton, New Jersey
– October 2, 2007
Ranbaxy Pharmaceuticals Inc. (RPI),
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 (U.S. FDA)
to manufacture and market Clarithromycin for Oral Suspension,
USP, 125 mg/5 mL and 250 mg/5 mL. Ranbaxy is the first
company to have been granted a generic approval for
the Oral Suspension form along with Clarithromycin Tablets.
Total annual market sales for Clarithromycin were $99.7
million with suspension sales totaling $25.3 million
(IMS – MAT: June 2007).
“We are pleased to receive this
FDA approval for Clarithromycin for Oral Suspension,
an anti-infective agent that will add depth and breadth
to our product line of anti-infectives that also includes
Clarithromycin tablets. RPI will be in a position to
offer both dosage forms for this molecule that will
distinguish Ranbaxy in the market place. This approval
further expands our product portfolio of affordable
generic alternatives and will be shipped immediately
to all classes of trade,” according to Jim Meehan,
Vice President of Sales and Distribution for RPI.
The Office of Generic Drugs, U.S. FDA,
determined the Ranbaxy formulation to be bioequivalent
and to have the same therapeutic effect as that of the
reference listed drug Biaxin® Granules (Clarithromycin
for Oral Suspension, USP), 125 mg/5 mL and 250 mg/5
mL of Abbott Laboratories. Clarithromycin for oral suspension,
USP, is indicated for the treatment of mild to moderate
infections caused by susceptible strains of the designated
microorganisms in a number of conditions including:
Pharyngitis/Tonsillitis, Community-Acquired Pneumonia,
uncomplicated skin and skin structure infections and
disseminated mycobacterial infections.
Ranbaxy Pharmaceuticals Inc. (RPI)
based in Jacksonville, Florida, is a wholly owned subsidiary
of Ranbaxy Laboratories Limited (RLL), India’s
largest pharmaceutical company. RPI is engaged in the
sale and distribution of generic and branded prescription
products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, India’s
largest pharmaceutical company, 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.
*Biaxin® Granules (Clarithromycin for Oral Suspension,
USP) is a registered trademark of Abbott Laboratories
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