German pharmaceutical company Schering said yesterday its application to market oral contraceptive YAZ for premenstrual dysphoric disorder has been deemed approvable by the US Food and Drug Administration.

Crucially, while stopping short of a full approval for the application for PMD, a severe form of premenstrual syndrome, the FDA has not asked for any additional clinical data on the product, so Schering is not expecting a long hold-up for the review. The company said it expects a final decision on YAZ (drospirenone plus ethinyl estradiol) in the first quarter 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 seven days of placebo. Another low-dose oestrogen variant, called Yasminelle, was cleared in the USA in August.

Schering has forecast peak annual sales for YAZ of around 200 million euros, providing it wins approval for PMDD as well as contraception. The company got a similar approvable letter for the latter indication in 2004.

- Meanwhile, a poll of 16 analysts has suggested that Schering will post sales of 5.25 billion euros in 2005 and operating profits of 925 million euros. The company is due to present its 2005 results on February 20. In 2006 and 2007, sales will rise to 5.6 billion and 5.9 billion euros, respectively, according to the analysts. Operating profit will rise to 1.05 billion euros this year, and then 1.13 billion euros in 2007, they predict.