Ranbaxy Gains FDA Approval To Market Amoxicillin And Clavulanate Potassium For Oral Suspension USP

Main Category: Ear, Nose and Throat
Also Included In: Infectious Diseases / Bacteria / Viruses
Article Date: 01 Feb 2007 - 0:00 PDT

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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 market Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg (base) / 5 mL. The Division of Bioequivalence has determined the Ranbaxy formulation to be bioequivalent and, therefore, therapeutically equivalent to Augmentin(R) ES-600 for Oral Suspension, 600 mg/42.9 mg (base) / 5 mL of GlaxoSmithKline. Augmentin(R) ES-600 for Oral Suspension has combined sales of $216 million with sales of 600 mg/42.9 mg (base) / 5 mL totaling $136.9 million in the suspension market (IMS -- MAT: September 2006).

Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg (base) / 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae, H. influenzae, or M. catarrhalis characterized by the following risk factors: antibiotic exposure for acute otitis media within the preceding 3 months and either of the following -- age less than 2 years or daycare attendance.

"We are delighted to offer yet another dosage form of Amoxicillin based on the skills and talents that are available through our parent company, Ranbaxy Laboratories Limited. This again demonstrates our depth and breadth of expertise and adds to our ever-expanding product portfolio, complimenting our commitment to bring affordable generic alternatives to the U.S. healthcare system. This product will be available in April 2007," said 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 9 countries.

Augmentin(R) is a registered trademark of GlaxoSmithKline.

Ranbaxy Laboratories Limited (RLL)
http://www.ranbaxy.com