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| Fda approval for Lybrel |
The Food and Drug Administration – FDA formally released the
approval of Lybrel – the first continuous use drug product for
avoidance of pregnancy, made by Wyeth Pharmaceuticals, Philadelphia
- PA, on 22nd May 2007.
Lybrel, the new contraceptive, comes in the 28 day pill pack with
low-dose combination tablets that contain 90 mcg of progestin,
Levonorgestrel and 20 mcg of estrogen, Ethinyl Estradiol which are
the active ingredients available in the other approved oral
contraceptives. Continuous contraception functions similarly as the
21 days plus 7 days interval cycle. The pill prevents the monthly
preparation for pregnancy by inhibiting the production of hormones
that enables pregnancy.
Other contraceptive pill therapies have placebo i.e. pill-free
period varying from 4 to 7 days that stimulate the menstrual cycle.
Lybrel is typically designed to be taken without placebo periods.
The women using Lybrel would not have scheduled menstrual periods
but may experience unexpected, penetrating bleeding of spotting.
The two different clinical studies spanning one year each, involving
over 2,400 women of ages between 18 and 49 years, were conducted for
the safety and efficacy of Lybrel. Healthcare professionals and
patients are advised that while planning the use of Lybrel, the
expediency of having no scheduled menstruation periods should be
evaluated against the inconvenience of unscheduled bleeding or
spotting. The event of unscheduled bleeding reduces over a period of
time in most of the females who continue taking Lybrel through out
the year.
During the initial clinical studies, 59 percent of the participating
women who used Lybrel for the year showed no bleeding or spotting
during the last month of the study. The approval of Lybrel ends the
thorough review process that incorporated expert advice from the
meeting of an FDA’s Reproductive Health Drugs advisory committee and
the chances for the public comments on issues related to hormone
contraception. |
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