Navigation Links
Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
Date:8/20/2007

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


'/>"/>
SOURCE Ranbaxy Pharmaceuticals Inc.

Copyright©2007 PR Newswire.

Related medicine technology :

1. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
2. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
3. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
4. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
5. Major Manufacturer of Unapproved and Adulterated Drugs
6. FDA Advises Manufacturers to Test Glycerin for Possible Contamination
7. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
8. New Report Looking at Chiral Technologies Analyzes the Global Market Growth Forecasts Driven By Two Very Important Components as Single Isomer Drugs and Single Enantiomer Pharmaceuticals
9. New Data on Market-Leading Velcade (Bortezomib) for Injection Further Strengthen Role in Previously Treated Multiple Myeloma
10. Clinical Trial Excellence: Shaping Markets Through Early Communication of Clinical Trial Data
11. New Study Reveals Limitations of a Complex and Challenging Global Tuberculosis Drug Marketplace
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology:
(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):