Cyclafem 7/7/7
NDC Package 76413-104-28

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Cyclafem™ 7/7/7 (norethindrone and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Method(1)   % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women ContinuingUse at One Year3 Typical Use1(2) Perfect Use2(3) (4)Chance4 85 85 Spermicides5 26 6 40Periodic abstinence 25  63Calendar  9 Ovulation Method  3 Sympto-Thermal6  2 Post-Ovulation  1 Cap7   Parous Women 40 26 42Nulliparous Women 20 9 56Sponge   Parous Women 40 20 42Nulliparous Women 20 9 56Diaphragm7 20 6 56Withdrawal  19   4  Condom8   Female (Reality®) 21 5 56Male 14 3 61Pill 5  71Progestin Only  0.5 Combined  0.1 IUD   Progesterone T 2.0 1.5 81Copper T380A 0.8 0.6 78LNg 20 0.1 0.1 81Depo-Provera® 0.3 0.3 70Norplant and Norplant-2 0.05 0.05 88Female Sterilization 0.5 0.5 100Male Sterilization 0.15 0.10 100Adapted from Hatcher et al., 1998, Ref. #1. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides.9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.Cyclafem™ 7/7/7 has not been studied for and is not indicated for use in emergency contraception._________________________________________________________________________________________________

Central Texas Community Health Centers

ANDA076338

ANDA - A product marketed under an approved Abbreviated New Drug Application.

11-16-2010

12-31-2019

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No