Lomedia 24 Fe
NDC Package 65162-316-84

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

3 EA

-

Lomedia 24 Fe tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Oral contraceptives are highly effective. Table 2 lists the typical unplanned pregnancy rates for users of combination 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 2Percentage 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.   % of Women Experiencing an UnintendedPregnancy within the First Year of Use% of WomenContinuing Use at OneYear3 Method(1)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 361Pill 5   71Progestin Only  0.5 Combined  0.1 IUD   Progesterone T 2.0 1.5 81Copper T 380A  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 0.5100Male Sterilization 0.15 0.10  100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75%9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.Source: Trussell J, Stewart F, 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 reason2  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 reason3  Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year4  The percentage of women becoming pregnant noted 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% became pregnant in one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandon contraception altogether5  Foams, creams, gels, vaginal suppositories and vaginal film6  Cervical mucous (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the postovulatory phases7  With spermicidal cream or jelly8  Without spermicides9  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 ageClinical StudiesIn a clinical study, 743 women, 18 to 45 years of age, were treated with Lomedia24 Fe for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for Lomedia24 Fe was 1.82.

Amneal Pharmaceuticals Of New York, Llc

ANDA078267

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

12-20-2013

12-31-2017

I

No