Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
August 20, 2007 - 7:07pm
PRINCETON, N.J., Aug. 20 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc.
(RPI), 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 market Hydrocodone Bitartrate and
Acetaminophen Tablets USP, 7.5 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg, and 10
mg/325 mg strengths. The Office of Generic Drugs, U.S. Food and Drug
Administration, has determined the Ranbaxy formulations to be bioequivalent
and have the same therapeutic effect as that of the reference listed drugs
as follows: 10 mg/325 mg Norco Tablets of Watson Pharmaceuticals Inc., 5
mg/500 mg Vicodin Tablets, and 7.5 mg/750 mg Vicodin ES Tablets both of
Abbott Laboratories, and 10 mg/500 mg Lortab Tablets of UCB Inc. Total
annual market sales for Hydrocodone Bitartrate and Acetaminophen Tablets
were $390.6 million (IMS - MAT: June 2007).
"Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the
relief of moderate to moderately severe pain, and Ranbaxy is pleased to
receive final FDA approval for multiple strengths of this product. These
approvals further expand our product portfolio of affordable generic
alternatives and will be launched in a November 2007 time period to all
classes of trade," according to Jim Meehan, Vice President of Sales and
Marketing for RPI.
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, 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.
*Vicodin(R) ES Tablets is a registered trademark of Abbott Laboratories
*Norco(R) Tablets is a registered trademark of Watson Pharmaceuticals Inc.
*Lortab(R) Tablets is a registered trademark of UCB Inc.
CONTACTS: Charles M. Caprariello
Vice President, Corporate Communications
Ranbaxy Inc.
(609) 720-5615
Edwige Buteau
RF Binder Partners Inc.
(212) 994-7517
edwige.buteau@rfbinder.com
Anuj Baveja
RF Binder Partners Inc.
(212) 994-7552
anuj.baveja@rfbinder.com
Interesting....Walgreen's always uses Ranbaxy products for a bunch of their benzo generics, particularly lorazepam (Ativan), and I've always found them to be as good as if not better than Mylan's. Also interesting that Ranbaxy is the ONLY pharma corp. that still manufactures barbiturate sleeping pills like Seconal, though I've never seen one or have never even seen them prescribed. I remember there was some big to-do about Ranbaxy buying the rights from Lilly several years ago (I think, not positive)...Do docs - or anyone - still use them?