Sanofi-Aventis has this morning said a long-acting version of its big selling insomnia drug, Ambien (zolpidem), has been cleared by the US Food and Drug Administration for both sleep induction and sleep maintenance – a new label.
The original Ambien is the country’s number one sleep drug, with 2004 sales of $1.8 billion dollars, but is facing competition from Sepracor’s Lunesta (eszopiclone) and from copycat offerings looming on the horizon following patent expiry in 2006 [[08/04/05f]], [[31/05/05d]]. The company had expected to be selling Ambien CR in the USA by mid-2005 but received an approvable letter from the US Food and Drug Administration in April [[12/04/05c]].
Sanofi, which is also pushing a second insomnia compound – eplivanserin – through development, recently said that despite the substantial launch costs associated with the introduction of Ambien CR and its new obesity drug Acomplia (rimonabant), it forecasts full year earnings per share to jump 20% compared with previous guidance of 18% [[31/08/05a]].
