07:00 , Mar 12, 2012 |  BC Week In Review  |  Clinical News

Angeliq drospirenone/estradiol regulatory update

FDA approved a 0.25 mg/0.5 mg dose of Angeliq drospirenone/estradiol to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. Bayer already markets 0.5 mg/1 mg drospirenone/estradiol for the...
07:00 , Sep 20, 2004 |  BC Week In Review  |  Clinical News

Angeliq estradiol/drospirenone regulatory update

SHR subsidiary Berlex Laboratories (Montville, N.J.) received an FDA approvable letter for Angeliq tablets, a once-daily hormone replacement therapy (HRT), to treat menopausal symptoms. Berlex said FDA requested additional manufacturing information. Angeliq already has EU...
07:00 , Sep 15, 2004 |  BC Extra  |  Company News

Berlex receives Angeliq approvable letter

Berlex received an FDA approvable letter for its Angeliq oral, once-daily estradiol and drospirenone low dose hormone replacement therapy (HRT) to treat menopausal symptoms. The agency requested additional manufacturing information. Berlex, a subsidiary of Schering...
07:00 , Jun 28, 2004 |  BioCentury  |  Strategy

Schering's core pipeline

Schering's core pipeline Product Indication Status Partner Women's healthcare Yasmin drospirenone low dose Oral contraceptive Registration Acne Ph III (registration 2005) Premenstrual dysphoric disorder (PMDD) Ph III (data 4Q04; registration 2005) Menostar transdermal ultra-low...
07:00 , Jul 14, 2003 |  BC Week In Review  |  Clinical News

Angeliq oral once-daily estradiol and drospirenone low dose hormone replacement therapy regulatory update

SCH said the EU concluded the Mutual Recognition approval procedure for Angeliq and that the company will launch the product this fall. The reference state, the Netherlands, approved Angeliq last year to treat menopausal symptoms...
08:00 , Dec 23, 2002 |  BC Week In Review  |  Clinical News

Angeliq oral once-daily estradiol and drospirenone regulatory update

The Netherlands granted marketing approval to SCH for its Angeliq hormone replacement therapy (HRT) to treat menopausal symptoms and to prevent osteoporosis in women. In October, the FDA issued a non-approvable letter for Angeliq to...
08:00 , Dec 18, 2002 |  BC Extra  |  Company News

Angeliq approved in the Netherlands

The Netherlands granted marketing approval to Schering (FSE:SCH; SHR) for its Angeliq oral once-daily estradiol and drospirenone hormone replacement therapy (HRT) to treat menopausal symptoms and to prevent osteoporosis in women. In October, the FDA...
07:00 , Oct 21, 2002 |  BC Week In Review  |  Clinical News

Angeliq oral once-daily estradiol and drospirenone regulatory update

SCH subsidiary Berlex Laboratories (Montville, N.J.) received a non-approvable letter from the FDA for Angeliq HRT therapy to treat menopausal symptoms. Earlier this month, SCH received a non-approvable letter for an HRT patch containing estradiol...
07:00 , Oct 18, 2002 |  BC Extra  |  Company News

Schering gets another HRT non-approvable letter

Schering (FSE:SCH; SHR) received a non-approvable letter from FDA for its Angeliq oral once-daily estradiol and drospirenone HRT therapy to treat menopausal symptoms. SHR would not discuss the contents of the FDA letter. Earlier this...