July launch is slated for desogestrel/ethinyl estradiol tablets for female oral contraception, following FDA approval April 22. The approval was based on a 1,226-patient Phase III study. The ethinyl estradiol dose is 20 mcg in conjunction with 150 mcg desogestrel for 21 days, followed by two days of placebo, then five days of 10 mcg ethinyl estradiol to complete the cycle. Commonly-used birth control pills have a seven-day placebo cycle after 21 days of estrogen therapy. Many physicians prescribe estrogen during that period to reduce incidence of migraines, dysmenorrhea and premenstrual syndrome, Organon said...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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