Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for SEASONIQUE™ (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive, doesn’t need additional clinical data for USFDA approval as announced by Barr Pharmaceuticals, Inc. which will continue to work with FDA to resolve outstanding issues including product labeling and post marketing commitments.
SEASONIQUE™ is an oral contraceptive with a unique regimen of 84 days of combination therapy, followed by seven days of unopposed estrogen. Under this extended-cycle regimen, women take active tablets of 0.15 mg levonorgestrel/0.03 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from monthly to four per year. Read more.
Duramed Pharmaceuticals, Inc. is a subsidiary of Barr Pharmaceuticals, Inc.
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» SEASONIQUE™ Extended-Cycle Oral Contraceptive, USFDA Approved for the Prevention of Pregnancy from ThePharmVoice
The USFDA recently approved Duramed Pharmaceuticals, Inc. and Barr Pharmaceuticals, Inc.’s New Drug Application (NDA) for SEASONIQUE™ (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-... [Read More]
Tracked on: May 31, 2006 3:36 AM | Permalink to Trackback