Schering AG of Germany is facing a delay of up to three months in the US approval of its oral contraceptive product YAZ, the company said today.
The Food and Drug Administration has postponed its review deadline for the application for YAZ (drospirenone plus ethinyl estradiol) until the first quarter of 2006, said the firm. Schering was issued an approvable letter for YAZ by the FDA in 2004, requesting additional clinical data.
Schering had been hoping to launch the product before the end of the year. In a statement, Phil Smits, head of gynaecology and andrology at the company, said: "We are optimistic that YAZ will be available to women in the first half of 2006.”
YAZ is a low-dose form of Schering's fast-growing oral contraceptive Yasmin, and is taken for 24 days followed by 4 days of placebo pills. The normal dosing for oral contraceptives is 21 days of active pills with 7 days of placebo. Another low-dose oestrogen variant, called Yasminelle, was cleared in the USA in August.
Yasmin saw its sales advance 34% to 421 million euros in the third quarter of 2005, making it one of Schering's biggest drugs, although it is facing a challenge by generic manufacturer Barr Laboratories.