US regulator’s drug decision setback for Reckitt
US regulators have approved two rival versions of Reckitt Benckiser’s heroin addiction drug, rejecting its attempt to block the products on the grounds that stricter packaging rules were needed to protect children.
Reckitt makes most of its profits from Suboxone, a treatment containing buprenorphine that helps people addicted to opiates.
The company warned that generic competitors were likely to enter the market since its exclusivity status expired in 2009. Hoping to shore up its position, Reckitt has been campaigning to persuade the US Food and Drug Administration (FDA) to refuse applications from manufacturers unless they adopt stringent packaging standards.
Reckitt, which has a consumer healthcare factory in Hull, said it had been informed by the FDA that the regulator had approved two generic versions of Suboxone tablets in the US.