Thursday, April 17, 2008

Shionogi Receives Marketing and Manufacturing Approval for Irbetan 50mg and 100mg Tablets

April 17, 2008 -- Shionogi & Co., Ltd. today announced that it received marketing and manufacturing approval for 50mg and 100mg formulations of Irbetan® (generic name: Irbesartan), a hypertension treatment, on April 16. Shionogi plans to launch the product pending its National Health Insurance (NHI) price listing.
Discovered by French pharmaceutical company Sanofi-Aventis and codeveloped in overseas countries by Sanofi-Aventis and Bristol Myers Squibb, a U.S. pharmaceutical company, Irbesartan is a long-acting angiotensin II receptor blocker (ARB). In addition to having a stable hypotensive effect lasting 24 hours on mild to severe hypertension, Irbesartan has received a high evaluation outside Japan since its launch in 1997 as the only ARB with evidence of its renoprotective action in early to end stage nephropathy patients from the large-scale clinical trials including IDNT and IRMA 2 which are often cited in the major guidelines abroad.

The drug is on the market in 86 countries. Worldwide sales in 2007 totaled about 300.0 billion Japanese yen, making it one of the leading ARB brand. In conjunction with the approval of Irbetan®, which offers outstanding renoprotective action, Shionogi has enlisted Atsuya Furuta, former manager of the Yakult Swallows pro baseball team to symbolize the product character with his image for our effective promotional activities to healthcare providers under the catch-phrase of ‘Beat the CKD’. This initiative is aimed at raising awareness of the importance of renal protection and of the diagnosis and treatment of chronic kidney disease (CKD).

(Source: www.pharmalive.com)

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