Reuters: Regulatory News: UPDATE 1-Reckitt loses bid to change U.S. drug packaging rules

Reuters: Regulatory News Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com

UPDATE 1-Reckitt loses bid to change U.S. drug packaging rules Feb 25th 2013, 08:47 Mon Feb 25, 2013 3:47am EST * FDA rejects Reckitt petition on heroin addiction drug packaging * FDA approves two generic versions of Reckitt's Suboxone * Shares in Reckitt open down 3.9 pct LONDON, Feb 25 (Reuters) - The U.S. drugs regulator has rejected goods manufacturer Reckitt Benckiser's call for stricter packaging for its heroin addiction treatment, instead approving generic production for the drug. The British company's pharmaceuticals division makes most of its profit from Suboxone, a treatment containing buprenorphine, for recovering heroin addicts. Last year, Reckitt voluntarily withdrew the sale of Suboxone tablets in the U.S. in favour of an individually sealed film version, citing a higher risk of children mistakenly getting their hands on the tablets. With the entry of generic competitors, it has been campaigning to persuade the U.S. regulator, the Food and Drug Administration, to adopt more stringent packaging standards and better education for all manufacturers of the drug. However, the FDA found that existing programmes were sufficient, Reckitt said on Monday, and had approved two generic versions of Suboxone in the U.S. "The direct risks are now those of a generic takeover of the tablet segment and substitution of film by generics," said analysts at Investec, cutting their stance on Reckitt's shares to 'sell' from a previous 'hold'. "But it also feels like the FDA's patience has been tested." Investec estimates that the tablets in the U.S. represented around 5 percent of Reckitt's group profits in 2012 and film a further 10 percent. Shares in Reckitt - which have had a strong run recently, up around 20 percent since October - opened down 3.9 percent at 4,340 pence on Monday. Link this Share this Digg this Email Reprints

You are receiving this email because you subscribed to this feed at blogtrottr.com. If you no longer wish to receive these emails, you can unsubscribe from this feed, or manage all your subscriptions