Ranbaxy Receives Tentative Approval From Us FDA To Market Risperidone Oral Solution

Main Category: Schizophrenia
Also Included In: Pharma Industry / Biotech Industry
Article Date: 07 Aug 2006 - 0:00 PDT

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Ranbaxy Laboratories Limited (RLL) announced today that the Company has received tentative approval from the U.S. Food and Drug Administration (US FDA) to manufacture and market Risperidone Oral Solution, 1 mg/mL.

Risperdal® (risperidone) is indicated for the treatment of schizophrenia. Total annual market sales for risperidone oral solution were $66 million (IMS - MAT: March 2006).

"We are pleased to receive this tentative approval for Risperidone Oral Solution. This product represents a future opportunity for Ranbaxy and will be launched following final approval from the US FDA," according to Jim Meehan, Vice President of Sales and Marketing for RPI, USA.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, 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 8 countries.

*Risperdal® is a registered trademark of Janssen Pharmaceutica Products, L.P.

http://www.ranbaxy.com