FDA turns down Reckitt's bid to block rival products
27 Feb 2013
US regulators, while approving two generic versions of Reckitt Benckiser's heroin addiction drug, have rejected its bid to block rival products on the grounds that stricter packaging rules were called for to protect children.
The pharmaceuticals division of the British consumer health goods company makes most of its profit from Suboxone, a treatment containing buprenorphine that allows opiate addicted people cope with ceasing their use.
The company had warned that generic competitors were likely to enter the market following expiry of its exclusivity status in 2009.
Hoping to strengthen its position, Reckitt had been campaigning to persuade the US Food and Drug Administration (FDA) to turn down applications from manufacturers unless they adopted stringent packaging standards.
However, on Monday, Reckitt said it had been informed by the FDA that it had approved two generic versions of Suboxone tablets in the US.
Further, the FDA referred in its letter to having received assertions that Reckitt's petition was an anti-competitive practice. It said it would refer the company to the Federal Trade Commission.
