Ranbaxy's peptic ulcer drug cleared for US launch

India's Ranbaxy Pharmaceuticals said it has obtained clearance from the US Food and Drug Administration for selling the generic version of its of peptic ulcer drug Robinul.

To be sold in 1mg and 2mg dosages, the tablet will be a generic version of Sciele Pharma's Robinul which has an annual market of $26 million in the US.

The glycopyrrolate tablet is likely to be launched in December, and it expected to generate $26 million annually. The tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

Ranbaxy Pharmaceuticals (RPI) is a wholly-owned subsidiary of Ranbaxy Laboratories, which is now owned by Japan's Daiichi Sankyo.

Talking about the tablet, Jim Meehan, vice president of sales and distribution, said, "This product formulation will be launched in the October-December quarter to all classes of trade and further expands the number of affordable generic product formulations offered by RPI, that will be of benefit to patients, healthcare professionals and the US healthcare system.''

RPI is based in Jacksonville, Florida, and is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.

Ranbaxy's foray into novel drug delivery systems has led to proprietary "platform technologies", resulting in a number of products under development. The company is present in over 125 countries and has an international portfolio of affiliates, joint ventures and alliances, and ground operations in 49 countries and manufacturing operations in 11 countries.