Schering AG yesterday said that regulatory authorities in the Netherlands have given the thumbs up to its oral contraceptive, Yasminelle (ethinyl estradiol and drospirenone), a new lose-dose oestrogen formulation of its top-selling Yasmin.
“Yasminelle will build upon the success of Yasmin, which is the number one oral contraceptive worldwide,” said Philip Smits, Head of Gynaecology and Andrology and Schering. The company will use the Dutch approval to seek mutual recognition across Europe.
Yasmin saw a 34% boost in net sales during the first six months to 256 million euros [[22/07/05e]] but the company is looking to build further on the portfolio’s success. As well as this new 21-day Yasminelle regimen, it is also awaiting US approval for a 24-day regimen of YAZ – another drospirenone-containing oral contraceptive. YAZ was issued an approvable letter by the US Food and Drug Administration in 2004, requesting additional clinical data, but a further decision is anticipated later this year [[25/11/04d]].