FDA批准辉瑞公司的 Estrostep口服避孕药用于治疗痤
WASHINGTON (Reuters Health) - The US Food and Drug Administration (FDA) has approved Pfizer Inc.'s oral contraceptive Estrostep (norethindrone acetate/ethinyl estradiol) as a treatment for moderate acne, according to an FDA notice issued on Friday.
The FDA said it approved Estrostep for the treatment of acne vulgaris in women aged 15 years and older who have no known contraindications to oral contraceptives, desire oral contraception, have achieved menarche and are unresponsive to topical anti-acne medications.
In 1997, the FDA also approved Johnson & Johnson's Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) for the same indication.
But according to researchers, Estrostep, which Pfizer got as part of its acquisition of Warner-Lambert in June 2000, could offer women another important option.
In previously released clinical studies, these researchers noted that Estrostep was shown to reduce acne-related lesions by 48% and inflammatory acne by 56% when compared to placebo over a 6-month period.
The studies were presented at the annual meeting of the American College of Obstetrics and Gynecology by Dr. Richard Derman of the University of Illinois in Chicago, who conducted the trials as part of Pfizer's supplemental new drug application (sNDA) that sought to have Estrostep approved as a treatment for acne.
At the time, Derman said the results were significant because the Estrostep tablets offered the "least amount of hormone to get the needed effect." That meant that women could take advantage of the acne-associated benefits of oral contraceptives without having the side effects associated with higher amounts of estrogen, such as weight gain.
At the close of trading on the New York Stock Exchange on Friday, shares of Pfizer closed up 0.26 to 40.02., 百拇医药
The FDA said it approved Estrostep for the treatment of acne vulgaris in women aged 15 years and older who have no known contraindications to oral contraceptives, desire oral contraception, have achieved menarche and are unresponsive to topical anti-acne medications.
In 1997, the FDA also approved Johnson & Johnson's Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) for the same indication.
But according to researchers, Estrostep, which Pfizer got as part of its acquisition of Warner-Lambert in June 2000, could offer women another important option.
In previously released clinical studies, these researchers noted that Estrostep was shown to reduce acne-related lesions by 48% and inflammatory acne by 56% when compared to placebo over a 6-month period.
The studies were presented at the annual meeting of the American College of Obstetrics and Gynecology by Dr. Richard Derman of the University of Illinois in Chicago, who conducted the trials as part of Pfizer's supplemental new drug application (sNDA) that sought to have Estrostep approved as a treatment for acne.
At the time, Derman said the results were significant because the Estrostep tablets offered the "least amount of hormone to get the needed effect." That meant that women could take advantage of the acne-associated benefits of oral contraceptives without having the side effects associated with higher amounts of estrogen, such as weight gain.
At the close of trading on the New York Stock Exchange on Friday, shares of Pfizer closed up 0.26 to 40.02., 百拇医药