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:8/18/2017)... , Aug. 18, 2017  Nortis today announced the ... funding for the third year of a Small Business ... National Institute of Neurological Disorders and Stroke (NINDS).?  ... Nortis ParVivo ... ...
(Date:8/17/2017)... 2017 MJAC2017 , the premier cannabis event ... today reveals its leading lineup. MJAC2017 ... cannabis innovator specializing in the development of pharmaceutical and consumer ... Rambridge™ and The Green Organic Dutchman are gold sponsors for ... silver sponsors. ...
(Date:8/17/2017)... DarioHealth Corp. (NASDAQ: DRIO), a leading ... big data solutions, announced today that it has ... investors for the sale of shares of the ... newly designated Series B Convertible Preferred Stock in ... conduct a closing with respect to the offerings ...
Breaking Medicine Technology:
(Date:8/18/2017)... ... August 18, 2017 , ... Goss & Associates ... residential and commercial clients in the greater Houston region, is helping locally recognized ... the fight against cancer. , Founded by Tony and Amber Bender after losing ...
(Date:8/18/2017)... , ... August 18, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... will lift the veil on false teachings pertaining to the mother of the Savior whom ... you see a far different picture of the role of this historical woman. , ...
(Date:8/18/2017)... ... August 18, 2017 , ... “Our Mountains to Climb: A Journey ... couple that grew stronger together through the faith they shared to overcome struggles in ... the creation of published author, Barbara J. Corcoran, a retired teacher and happily married ...
(Date:8/18/2017)... ... ... “Depressed: Super Heroes of the Bible”: a gripping and potent text that ... these tales may have on the reader’s life. “Depressed: Super Heroes of the Bible” ... spends much of her time enjoying nature and her family in West Virginia. ...
(Date:8/18/2017)... ... ... “Steve the Snake”: an entertaining and moral-based short story about an unkind snake ... Flash Haskins Jr., a husband, father and grandfather who served as a U.S. Marine, ... short stories for children and teens. My goal is to teach kids to use ...
Breaking Medicine News(10 mins):