Abbott receives FDA letter regarding hydrocodone with acetaminophen

Abbott has announced it has received a complete response letter from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for a controlled-release variety of hydrocodone with acetaminophen.

The company explains it is evaluating the FDA’s correspondence, will then discuss the NDA letter with the body and provide an update when appropriate to do so.

Abott is seeking for the therapy to be the first extended-release medication in the class to provide extended relief over a 12-hour period.

At present, currently-available short-acting hydrocodone and acetaminophen medications must be taken every four to six hours, the firm states.

It concludes: “Abbott is confirming its earnings-per-share forecast for the fourth quarter and full-year 2008. In addition, the company continues to expect double-digit earnings-per-share growth in 2009.”

Earlier this month, Miles D White, chairman and chief executive officer at Abbott, said the company remains “well-positioned”, with “strong” core growth franchises, including its emerging vascular business, which he said is becoming a “significant contributor” to the firm’s growth.

He made his comments as Abbott announced its third-quarter results for 2008, highlights of which included worldwide sales increasing by 17.6 per cent.